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More Past Events

New Features Make Product Show XX a Resounding Success

by Laurie Masiello, Masy Systems, with photos by Alastair Battson Photography

The 20 ^th  Annual ISPE Boston Area Chapter Product Show this year realized record attendance and many new features and enhancements.  Almost 2000 attendees were welcomed at over three hundred vendor booths.  Vendors hailed from thirty-one states and Canada, and presented opportunities to see their latest products and services.

Gorgeous weather and an unbeatable view of Gillette greeted Product Show attendees on October 5th.

This year there was a larger show floor and a new layout, with the keynote address located on the other side of the stadium.  What didn't change was the free food - the carving stations, varied and never-ending appetizers, cookies and desserts - and of course, the jumbo shrimp cocktail, our trademark!

Over 250 members participated in nine morning educational seminars and over 350 enjoyed insights and conversation with our keynote speaker, Jonathan Kraft, President of the Kraft Group and the New England Patriots. As a surprise, Mr. Kraft raffled off four tickets for premium seats on the 50-yard line to see the New England Patriots battle the New York Jets the following Sunday. What a treat for two lucky winners and their guests!

This year the expanded exhibit area made room for over 300 vendor booths and 2000 visitors.

Eight companies with job openings participated in the Career Fair, doing their part to reduce unemployment in Massachusetts, at least in the biopharmaceutical field!  Representatives from Abbott Bioresearch, Biogen Idec, Bristol-Myers Squibb, Genzyme, HireMinds, New England Controls, OPK Biotech and Vertex Pharmaceuticals posted their open positions, collected resumes and interviewed candidates.

As always, networking played an important role for visitors to the Product Show.

The day wrapped up with an exciting "after party" at nearby CBS Scene, where Patriots tight end Rob Gronkowski (graciously replacing the injured Jerod Mayo) mingled with guests and signed autographs. In addition, partygoers ate, drank, rested their tired feet after a long day and participated in late night raffles. Proceeds from the autograph-signing and raffles benefited the local nonprofit, Helping Our Troops, raising almost $1500 for this worthy cause.

Immediately following this hallmark event, surveys were sent to Product Show attendees and vendor participants. Feedback will help the Product Show Committee improve next year's experience. If you would like to participate on the Committee, please contact co-chairs Mark Sitcoske ( mark.sitcoske@hp-ne.com ) or Laurie Masiello ( lmasiello@masy.com ). The committee meets monthly to plan all facets of the Gillette event - it's not too early to get involved. Product Show XXI is less than a year away!  

A crowd of over 350 listened intently as Kraft delivered his remarks on life sciences, the Massachusetts economy and the New England Patriots.

What does an owner of the New England Patriots have in common with Product Show attendees, other than Gillette?  Over 350 made the trek to the opposite side of the stadium to find out (many pausing on the elevated walkway for a privileged peek at the Patriots on the practice field). And they weren't disappointed!

Jonathan Kraft, president and chief operating officer of The Kraft Group and president of the New England Patriots, opened his remarks by expressing his gratitude to the life sciences professionals whose efforts have brought health benefits to the lives of so many while at the same time creating a powerful engine of economic growth in Massachusetts. He also alluded to a life sciences "cluster" as one possible use for the "shovel ready" development site owned by the Krafts across Route 1 from Gillette.

Jonathan Kraft chats with Product Show Committee Chair Mark Sitcoske prior to the keynote address.

But Kraft had more to offer the audience than his respect for the life sciences, as he segued into a freewheeling discussion of the ins and outs of professional football. Topics included the Krafts' first meeting with management after purchasing the Patriots in 1994, the effects of the NFL salary cap, the management style of Parcells vs Belichick, what the team looks for in players, the recent NFL labor dispute and much, much more - all peppered with personal stories and anecdotes using wry humor that kept the audience smiling.

Even better, Kraft delivered his remarks with a degree of candor that made the audience feel like "insiders" - as if he had taken them into his confidence and were sharing opinions and insights not available to the general public - and he implored his listeners more than once to keep his remarks "confidential" and "off the record." All in all, he delivered a thoroughly entertaining and, at the same time, erudite potpourri of opinion, analysis and personal experience that kept the audience fully engaged and wishing for more.

 He concluded with a surprise, generously raffling off two pairs of tickets for premium seats at the Patriots game (vs. the New York Jets) the following Sunday. What a treat for two lucky winners and their guests! And a great way to wrap up an exciting keynote! 

  

It is hard to "compete" with all the attractions of the annual Product Show that engage attendees from noon until late in the late evening: state-of-the-art products, networking, Jonathan Kraft, terrific food and drink and more.  So this year the educational seminars were moved to the morning enabling a larger number of attendees to benefit without impacting their time on the show floor. Nine sessions - one long and eight short presentations - were held in the Gillette Clubhouse lounges and suites.  Those who took advantage of these educational sessions were riveted on the presenters, respected subject matter experts with a wealth of knowledge and experience in their chosen fields.

Morning educational seminars featured respected subject matter experts with a wealth of knowledge and experience.

The long "feature" program was the ELSIE Symposium held from 9:00am to 12noon in the West Clubhouse, Main Club Level. The speakers were Douglas Ball (Pfizer), Lewis Kinter (AstraZeneca Pharmaceuticals) and Daniel Norwood (Boehringer Ingelheim Pharmaceuticals). They covered practical solutions to address safety and quality concerns from extractable and leachable (E&L) compounds that can enter the product during the manufacturing process. The audience was treated to an extended period of knowledge transfer unavailable elsewhere.

Also at 9:00am on the Red Level, "Biotech 101: Trends in Facility Design" with Marc Pelletier of CRB and "Risk Management: Next Steps" with Emma Ramnarine of Roche were offered.  "Biotech 101" is a perennial favorite at the Product Show and attracted 62 attendees this year.  Then "Cold Chain Distribution" with Anthony Rizzo of Cold Chain Technologies was offered in parallel with the panel discussion, "Every Gold Medal Winner has a Coach and Mentors." Dan Gee moderated a terrific panel, which included Dan Button and Kathy Freitas of Draeger Medical, Armando Llorente of HRe-sources LLC, Kerry Harrison of MIT Lincoln Laboratory, Tawnya Johnson of the Boston Red Sox and Joseph Maressa, Fitzgerald, Stevens & Ford/OI Partners.

For the next pair of sessions, Jack Campion of Genzyme Corporation presented "Introduction to Validation" to a crowd of over 45 professionals while down the hall Michael Drues of Vascular Sciences engaged his audience with an interactive presentation on "Future Manufacturing & Packaging Challenges" (You can also catch Michael at the upcoming educational program on November 15th at the Genzyme Science Center in Framingham where he will present "Pharmacogenomics - What the Future Holds for Us!"). The last two sessions included Daryl Roll of Astro Pak Corporation on "Rouge: Monitoring, Measuring and Remediating in Water and Steam Systems" and Gwen Acton of Vivo Group on "Thriving at the Intersection of Science and Business."

Discussions with the speakers continued long after the presentations were over, always a good sign that the topics covered were timely and thought-provoking.  The morning of Educational Programs presented a wealth of industry and professional knowledge in an incredible forum for a price that couldn't be beat!  

 

How appropriate for the Hank Moes Lifetime Achievement Award to be presented at the 20th Annual Boston Area Chapter Product Show. The award is named for Hank Moes, the Chapter's first president, and this year honors André Walker, CPIP, 2010-11 Chairman of the ISPE International Board of Directors and longtime member and enthusiastic supporter of the Boston Area Chapter. 

Lifetime Achievement Award winner André Walker, CPIP (r) receives congratulations from Chapter President Brian Hagopian.

André has recently returned to the Boston area after a two-year tenure as Director of Manufacturing Engineering and Facilities for Biogen Idec's Large Scale Commercial Manufacturing Operation in Hillerod, Denmark. He  became a member of the ISPE International Board of Directors in  2003 and served as Vice Chair prior to assuming the Chairmanship in 2010. His many contributions to the Society include four years on the North American Affiliate Council, two of which he served as chair, and several years on the Boston Area Chapter Board, including terms as vice president, program chair, and president. He also holds the CPIP credential.

Upon accepting the award from Chapter President Brian Hagopian, André expressed his thanks to the Chapter and applauded its continued growth and success from humble beginnings two decades ago. His concluding message to the audience? He described the many hours he spent contributing to the Chapter and to the International Society as both personally and professionally fulfilling and urged members to get involved by volunteering to help plan and implement the Chapter's many activities. "You won't regret it!" he promised.

Congratulations to André and our heartfelt thanks for his many years worth of contributions to the Boston Area Chapter and the International Society! 

 

After a whole day standing on your feet meeting people at the Product Show, what better way to relax than to enjoy the evening with friends and colleagues at the After Party Celebration at CBS Scene. Over 400 people attended this year's gathering, filling up three floors of the restaurant to overflowing.

Product Show exhibitors and attendees celebrate at CBS Scene following the event.

A special attraction at this year's event was second-year Patriot's tight end, Rob Gronkowski. For two hours, attendees were able to have pictures taken with him and get his autograph. And, as if that weren't enough, the event raised $1400 in raffle donations for Helping Our Troops, a local nonprofit providing care packages to Massachusetts military personnel serving in Afghanistan and Iraq. The Chapter was able to donate $2000 to the organization,  and two lucky individuals won signed Patriots memorabilia for donating to the charity.

In fact, After Party attendance surpassed even our best-case estimates and nearly overwhelmed CBS Scene and its staff. Luckily, everyone was in a mellow mood after a long day of Product Show duty and more than content to roll with the punches. We're already looking for a local venue able to accommodate record crowds for next year's After Party and have our sights set on Toby Keith's I Love This Bar & Grill with its 85-foot long, guitar-shaped bar and Bullet the Mechanical Bull riding, anyone? 

Vendors planning to exhibit at the 20   ^th   Annual Boston Area Chapter Product Show got a special treat this year.  Not only were they invited to a Vendor Training Camp on September 8th where they received a tour of Gillette Stadium and heard presentations designed to improve their Gillette experience, they had a private luxury box viewing of the New England Patriots practice!

Vendor Training Camp attendees enjoy a free ride in the service elevator at Gillette.

The idea to create a Vendor Training Camp came from feedback from last year's attendees that noted vendors found it difficult to navigate around the stadium.  The Product Show committee responded by providing a tour of the stadium and planned presentations by Gillette personnel and SER Expo Services, the company who provides exhibitor support on show day.  A presentation on show etiquette and best practices was also developed as a refresher for exhibitors.

Participants ranged from first-time exhibitors to veterans of the Product Show from the early days at the Marriott in Newton and Howard Johnson's in Cambridge. Needless to say, all were thrilled at the opportunity to watch the pre-season NE Patriots practice! Questions were welcome throughout and ran the gamut from "Where's the loading dock?" to questions about the new after-party at CBS Scene. Vendors were able to see where their booth would be located and what companies would be located nearby.

Through their questions and comments, those who attended provided valuable insight on how to enhance next year's Gillette experience. Unfortunately, there is no guarantee that the 2012 Training Camp will include the private Patriot's practice. And that was an experience that will certainly be difficult to top!   

The program attracted a large turnout for two reasons: risk management is at the forefront of our industry and the event provided a rare opportunity to hear from two leading experts on the subject. 

Speakers Christina Mendat (l) and Susan Reilly (r) discuss risk management challenges during the Q&A session.

Risk management is more than performing a one-time risk assessment. Instead, it is about embedding it within the product and process lifecycle. The program focused on the application of risk management principles at two different points along the life cycle - in equipment design and in manufacturing - with the presenters describing how to better use risk management in the exciting field of "human factors" and the importance of the "root cause analysis" process. The EPC, under the able direction of Committee Chair Jack Campion, wanted to make certain that the program provided practical applications utilizing risk management principles and the event did not disappoint. Attendees queried the speakers well into the evening with challenging issues they had encountered in both R&D and operations. 

The evening began with registration in the second floor foyer with a gorgeous backdrop provided by the setting sun, the Boston skyline and the many boats docked along the Charles. Guests were welcomed by Amy Poole and Jamie Falzone from the Chapter office and enjoyed a networking cocktail reception with traditional New England fare prior to the presentations.

Chapter President Brian Hagopian opened the program by introducing several key areas the Chapter will be focusing on in the upcoming year: membership growth and retention, student chapters, educational curriculum expansion and increasing volunteer involvement across all committees. Brian went on to say, "the strength of the Boston Area Chapter is recognized at the national level of ISPE - as illustrated by our consecutive Chapter of the Year awards - and is due to our strong participation from volunteers."  Brian urged the audience to contact members of the Chapter's various committees to seek opportunities to volunteer.

Following Brian's comments, Meeting Manager Sean Brown introduced the two guest speakers. The first was Susan Reilly   ,   Principal, Reilly & Associates, with over 25 years of quality assurance, quality engineering, and regulatory compliance experience in the medical device field. Susan is an ASQ Certified Quality Engineer, Quality Auditor, and Quality Auditor-Biomedical and an RAB QMS Provisional Auditor and brings a wealth of industry experience with prior roles as Director, Quality Assurance and Compliance, at Medical Device Consultants and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group.

The second speaker was   Christina Mendat PhD, Director of Research and Human Factors at Radius Product Development where she provides technical oversight to the research and human factors teams and champions the integration of human factors in the product development process. Christina holds a doctorate in experimental psychology and ergonomics from North Carolina State University and is a member of the Human Factors and Ergonomics Society and the Association for the Advancement of Medical Instrumentation.

Susan's presentation, "Investigating the Problem: Use of Risk Management in CAPA Root Cause Analysis," was extremely interesting with many questions from the audience.  Susan pointed out that the FDA's current enforcement activities make it very clear that a robust CAPA process is essential and provided tangible examples illustrating where her clients used it to align with the agency's expectations. The real world examples provided the audience with tools for ranking and prioritizing CAPAs utilizing risk management.

Christina's presentation, "Mitigating Pharma Equipment Risk Through Human Factors" was equally informative and entertaining, with the audience participating in several lively discussions surrounding the topic. Christina described how companies go to great lengths to ensure that their products and equipment have met various standards, guidelines and technical feasibility - and that it leverages the appropriate technology - but that the same level of rigor, traceability and risk management is not applied to the human element of the product or equipment.

She continued by stressing that the integration of human factors and supporting research is a critical part of developing and maintaining the integrity of user requirements and mitigating any potential use-error risks. Her presentation included pharma case studies (e.g. bioreactor, filtration system) in which human factors integration resulted in equipment design that not only met product requirements from a technical perspective but also supported user requirements in a manner that fostered product compliance while minimizing use-errors. 

Mike Long concluded the meeting with a Q&A session which provided an opportunity for attendees to ask questions.  This part of the evening did not disappoint as the speakers addressed a range of questions from FDA expectations for formal risk management procedures to examples of "world class" use of the tools.  The speakers continued the discussion long after the formal part of the evening concluded, showing the level of interest from the audience for this important topic. 

Please visit the Chapter website at   www.ispeboston.org   for copies of the presentations. Or contact a member of the Educational Program Committee if you would like more information about this topic, if you have a subject you would like the Chapter to consider for future programs or would like to volunteer to join the Committee. 

The Sun Finally Shines on the Chapter’s Annual Golf Outing

by Christopher Opolski, Alexion Pharmaceuticals with photos by Brian Hagopian, Clearwater Consulting, and Christopher Opolski       

On October 17th, after a two month delay due to Mother Nature, the Boston Area Chapter hosted our annual golf tournament at the Indian Pond Country Club in Kingston, MA.  This year was the first time the Chapter hosted our golf tournament at Indian Pond and the club didn't disappoint.  This 18-hole championship course, which opened in 2001, measures almost 6800 yards over 160 acres of meticulously manicured grounds.  

The weather was the complete opposite from the originally scheduled August 15th.  Instead of the pouring rain, heavy clouds and high temperatures, the Chapter enjoyed a partly sunny day, lots of wind, and seasonable temperatures for October.  After a chilly morning the temperature warmed enough to justify the choice of shorts.  The weather gods predicted a few sprinkles in the morning but none were seen.  As with all our golf tournaments, the event wasn't just about the golf! Some of the special "extras" this year included Smith Optics sunglasses, cigars from Gina's Cigar Girls, Harpoon Beer to help golfers on the hole-in-one contest hole and tastings from Firefly Sweet Tea Vodka.

At the end of play, everyone enjoyed a cocktail reception in the club house.  During the reception, fourteen contestants who previously sunk a 10-foot putt during play had a chance to win $10K if they first sunk a 30-foot putt and then a final 50-footer.  Unfortunately, not one golfer even made the 30-footer so there was no chance at winning the $10K.  On the fifth, where a hole-in-one would pocket a golfer $10K, no one made it but of each foursome, the golfer with the closest shot on the green won a 6-pack of Harpoon beer.  After the relaxing cocktail reception, a spectacular buffet dinner was served followed by the presentation of awards and raffle prizes. Congratulations to all of the day's winners!

  The Winning Teams     

First Place (61)	Second Place (62)	Third Place (63)
The Wilkinson Companies	Middlesex Gases & Technologies	Robert W. Sullivan Engineering
Dan Paquette	Guy Sylvester	Paul Sullivan
Herb Aikens	Ron Perry	Tony Preteroti
Geoff Wilkinson Jr.	Ed Pendleton	Kevin Daly
Jeff Henderson	John Iannucci	Gary Doak

 

The Individual Winners     

	Men	Women
Longest Drive	Herb Aikens	Ann Coffon
Closest to Pin	Jay Zaino (5' 11")	Pat Nuggent (23' 3")
Straightest Drive	Gene Dennen	Ann Coffon

 Finally, proceeds from the raffle ticket sales benefited the Chapter's Joel Goldenberg Memorial Scholarship Fund.           

 Many, many thanks to our Golf Outing corporate sponsors: Superior Controls, Decco, GxP Automation, Arion Water, Aztec Technologies, RoviSys, Sentrol, Structure Tone, Aztec Technologies, Suffolk Construction's Red & Blue Foundation, Emerson Process Management, Middlesex Gases + Technologies, The Richmond Group. R. W Sullivan Engineering, The Wilkinson Companies, RFWalsh Collaborative Partners,  TRG Builders, SciTech Builders, ValSource & ConcordiaValSource and HDR - all of whom helped to make this event another big success for the Chapter.

 A special thanks to the tournament committee and volunteers during the event: Gene Dennen, Jim Grunwald, Michelle Greaney, Jennifer Grimley, Fasha Onorato, Mike Severino, and Brian Hagopian whose support helped make this event a huge success. 

For more pictures from this event go to the ISPE Boston Area Chapter Photo Gallery on our website.   

Beyond E.coli & CHO - Case Studies in Alternative Host Platforms 
by Lawrence Chew, Pfenex; Rachel Hoff, Percivia; and Shelly Henderson, with photos by Dan Gee, Biotech Drug Development Consultant and Barry Potts, Automatech.

On May 19 th , the ISPE Boston Area Chapter presented a Process Technology Transfer and Scale Up Program entitled "Beyond  E. coli  and CHO - Case Studies in Alternative Host Platforms."   The topic was chosen in response to our members' request for presentations on novel technology.  We were pleased that James Blackwell, Ph.D., former ISPE Boston Area President, offered to moderate the program, and grateful to Biogen Idec for the use of their auditorium and facilities in Cambridge. A brief summary of the program is presented below. Copies of the complete presentations are available online at the Chapter's website .

Left to right are the evening's speakers: Anna Tchoudakova, James Blackwell, Rachel Hoff, Shelly Henderson, and Lawrence Chew

Introduction by Shelly Henderson, MBA, former ISPE Vice President

The following historical tally of host cells used to produce FDA-approved recombinant therapeutics was presented to demonstrate how breakthrough the technology presented in this program truly is:

• 1982                 --- first approved was in E. coli
• 1982-1991         --- 12 microbial (E. coli and yeast), 2 CHO
• 1982-2011         --- 50+ microbial (E. coli and yeast) and 50+ mammalian (~40 in CHO) total.
• 2001                 --- first human cell host; since then, 2 additional by Shire.
  (Note: source BioProcess International)

Pfenex   Case Study -   Pseudomonas fluorescens  - by Lawrence Chew, Ph.D., Director of Fermentation Development at Pfenex, Inc.
The Pfenex  P. fluorescens  expression platform offers advantages similar to  E. coli , such as simple molecular cloning, short development timelines, short cultivation time (24-48 hours), simple defined medium and good scalability.  It improves upon E. coli  by providing the ability to generate and screen a large number of strains which support periplasmic expression of proteins that are soluble, active, with correct N-terminus, and with proper disulfide bond formation for proper folding, which allows fewer downstream processing steps. Secretion to the periplasm of proteins up to 250kDa in size at high titres (g/L) has been possible.

Pfenex has adopted an integrated approach to strain and process development for biopharmaceutical protein production that routinely involves good statistical experimental designs and data driven decisions. Extensive plasmid and host strain libraries that have been rationally developed using genomic data can be rapidly combined to generate thousands of unique strains that are then screened by robotically enabled sample processing and high throughput analysis methods.

Strain development is closely integrated with fermentation evaluation in mini and parallel bioreactors to ensure selected production strains are robust in scalable high cell density fed-batch cultures.  The high cell density fed-batch fermentation process involves a defined, mineral salts medium with only glycerol and ammonia feeds as carbon and nitrogen sources. It requires no animal-sourced components and has been optimized to ensure excess nutrients to support high cell density of up to 100g/L of dry cell mass in a fed batch process, attainable partially because   P. fluorescens   produces minimal inhibitory acid. For scale-up considerations, oxygen transfer and heat transfer (cooling) rates optimal to support high cell density   E. coli   or yeast fermentations also apply to P. fluorescens .

Protein recovery and purification development also involve efficiently screening multiple options at small scale followed by further optimization with scale-up in mind. Recovery and purification of soluble expressed proteins require fewer unit operations and result in higher yields than refolding proteins produced as insoluble inclusion bodies in   E. coli . Release of periplasmic proteins can be achieved by homogenization, osmotic shock, heat, chemical treatment or by solvent extraction. Solids separation can be achieved by continuous centrifugation, depth filtration, or tangential flow filtration. Purification steps are screened at small scale using robotic batch screening and microchip analysis, optimized at bench scale and evaluated at pilot scale. Standard as well as methods adapted to P. fluorescens  are used to show clearance of host contaminants (such as host cell proteins, nucleic acids and endotoxins) by standard purification processes to acceptable levels for injected drugs.

A Proof of Concept Timeline was presented showing a thousand strain construction and screening by week 3 after receipt of gene, production of standard and fermentation scouting by week 5, purification to deliver 50 mg of target protein at 99% purity by week 6, and delivery of 500mg at 99% purity by week 9. A Process and Development Timeline was presented showing 5-7 months to completion of a sufficiently developed process for transfer to a manufacturing site.

An actual case study was presented of the development and transfer of a fermentation process for a vaccine protein to a disposable bioreactor at a collaborator's facility. Pfenex has also successfully transferred its   Pseudomonas fluorescens   strains and fermentation processes to several manufacturing sites of collaborators, clients, and CMOs, and produced at up to 3,000L cGMP scale. The product that is nearest to market approval is currently being tested in a Phase III Clinical Trial.

Percivia Case Studies with the PER.C6 ^®   Human Cell Line - by   Rachel Hoff, Associate Scientist in the Upstream Process Development Group at Percivia, LLC.
Percivia, initially established as a joint venture of Crucell and DSM in Cambridge, MA in 2006, is focused on the development of PER.C6 ^® -based biosimilar and biobetter protein therapeutics and monoclonal antibodies (MAbs). Additionally, Percivia outlicenses the PER.C6 ^®  cell line and provides licensees with logistical support by training and advising on methods of recombinant protein production using the technology.  The origin, development, and safety testing of the PER.C6® cell line is documented in a Cell Substrate Biologics Master File submitted to the FDA. To date, approximately 40 clinical trials have been initiated world-wide with PER.C6®-based products with no adverse effects reported.

Mammalian, non-human cell lines dominate the field for manufacture of complex recombinant proteins and MAbs. Approximately 15 years ago, PER.C6 ^®  cells were created by rational design, that is, by transfecting human embryonic retina cells with adenoviral E1 transgenes which promote cell growth and inhibit apoptosis.  The advantages of the PER.C6 ^®  cell line are the elimination of non-human host cell impurities, proper protein folding and "humanized"  post-translational modifications, providing PER.C6 ^® -based products with a superior safety and efficacy profile compared to non-human cell line-based products.   

Additionally, Percivia has developed a tool box of high yielding cell culture production processes, including fed-batch and XD ^® , an Extreme Density process technology trademarked by DSM N.V.  All of the processes are chemically defined, animal-derived-component free, and utilize commercially available media. 

To develop a fed-batch process, a batch medium was chosen from a screen of commercial "off-the-shelf" media. Then, the feed media was developed as a concentrated form of commercial batch media components, supplemented with additional amino acids and vitamins to match relative consumption rates, and then adjusted to minimize osmolality and pH differences. To optimize the feeding strategy, a continuous feeding regimen was developed to minimize toxic nutrient spikes and the number of separate feeds was reduced to ease the operation.  The improved fed-batch platform process achieved cell densities of 25 million cells/mL and a yield of 8 g/L for a MAb. 

The XD ^®  process takes advantage of the PER.C6 ^®  cell's inherent ability to withstand high shear and grow to very high concentrations.  This process uses Refine's Alternating Tangential Flow (ATF) system to perfuse fresh medium through the bioreactor and remove metabolic by-products while retaining the cells and product. The constant environment of the XD ^®   process allows PER.C6 ^®   cells to grow exponentially during the entire run, resulting in extreme cell densities of 100-200 million cells/mL within two weeks with a record yield of 27 g/L for a MAb.  Since cells take up about 30% of the culture volume, the concentration of the MAb in the supernatant is actually closer to 40 g/L. 

In order to minimize effort when scaling up for GMP production, a small-scale model predictive of fed-batch bioreactor performance was developed with 250mL shake flasks (50mL working volume) with once-daily feeding. It is useful for clone screening, media/process development, and process troubleshooting. A case study of the scale up and transfer of the platform fed-batch process for a MAb was presented. Performance in a CMO's 250L disposable bioreactor was nearly identical to that in a 250mL shake flask, which validated the scale down models at the 250mL, 5L, and 50L scales.

Studies were also presented to compare three purification processes in terms of product recovery, impurity levels, cost, and scalability:

First, a protein A-based purification process was used as a benchmark, consisting of the following unit operations: clarification by sedimentation and 2-stage depth filtration, protein A column capture step, low pH viral inactivation and both CEX and AEX column polishing steps. The advantages of this process are high product yield and purity with minimal development effort.  However, there are several disadvantages, such as low impurity clearance in the clarification steps, low-throughput of packed-bed chromatography steps (Protein A, CEX, AEX), high cost due mainly to protein A resins, and the extensive feed conditioning (titration/dilution) required for CEX and AEX.

Second, a high capacity cation exchange column-based purification process was developed, consisting of the following unit operations: clarification by sedimentation and optimized 2-stage depth filtration, PEG precipitation of the MAb, MF/TFF for MAb resuspension, CEX column capture step, AEX membrane polishing step, viral inactivation and HIC column for aggregate removal. This scheme provides improved impurity clearance in the clarification steps while also preparing the feed stream for loading onto the CEX column at a high product concentration.  Due to replacement of protein A with a high capacity CEX capture and introduction of membranes in place of packed bed chromatography, this process results in reduced cost and process time.

Third, a process was developed using single-use membranes as replacements for all packed bed columns and consisting of the following unit operations: clarification by sedimentation and optimized 2-stage depth filtration, PEG precipitation of the MAb, MF/TFF, CEX membrane capture, AEX membrane polishing, viral inactivation, and HIC membrane polishing. The disadvantage of this option is a drop in product recovery from 90% to 70%. However, the fully disposable, membrane-based process allows for integrated, flow-through steps and reduced process time, equipment size, buffer use, and cost. In addition, the PEG precipitation step and the CEX capture membrane chromatography step were shown to be scalable over a 60-fold and 20-fold range, respectively.

In summary, the extensive data presented demonstrate that the PER.C6 ^®  cell line is an innovative, FDA-accepted cell line with documented origin and safety record.  Percivia has developed a versatile PER.C6 ^® technology platform for manufacture of recombinant proteins and MAbs at high yields and low cost. 
(Note: PER.C6 ^®  is a registered trademark of Crucell Holland B.V., and XD ^®  is a trademark of DSM N.V.)

A question and answer period followed each speaker's presentation. The ISPE Boston Area Chapter is grateful for the effort each made to present highly relevant, data based case studies for each of these breakthrough technologies. The authors can be reached via email as follows: Lawrence Chew at lchew@pfenex.com, Rachel Hoff at rhoff@percivia.com and Shelly Henderson at shelly_henderson@hotmail.com.

The program was conceived by Joyce Chiu, MBA, CPIP, Senior Project Leader, Honeywell Safety Products, Susan Dana Jones, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. and Shelly Henderson, MBA, Vice President, HCA.

Streamlining Extractables & Leachables Data & Plant Tour at Abbott 
by Michael Levesque, Olympus Biotech, with photos by Dan Gee, Biotech Drug Development Consultant

The June 16 ^th   educational program, "Streamlining Extractables & Leachables Data," was held at the Abbott Bioresearch Center in Worcester.  The program served to introduce the Extractables and Leachables Safety Information Exchange (ELSIE) consortium.  One need look no further than recent news headlines (BPA in Baby Bottles!) to understand the timeliness and importance of this subject to our industry.  This session was jointly sponsored by the Boston Area and New England Chapters.  

Left to right: Dr. William P. Beierschmitt (speaker), Dr. Carolyn Hsu (Abbott), Dr. Arthur Shaw (speaker)

The meeting was co-chaired by Peter Fox of RoviSys, Joshua Froimson of Abbott Bioresearch Center and Michael Levesque of Olympus Biotech Corporation.  Pete and Joshua are members of the New England Chapter and Mike is a member of the Boston Area Chapter and also serves on the Chapter's Educational Programs Committee (EPC).

Over 70 attendees representing the two Chapters gathered for the event.  The evening started with a sold-out, members-only tour of the Abbott Bioresearch Center facility, outstanding refreshments and an opportunity for networking. 

Joshua Froimson was the host for the event.  Jim Grunwald, President of the Boston Area Chapter; Kevin Chronley, President of the New England Chapter and Dan Gee, Member Service Committee volunteer for the Boston Area Chapter gave opening remarks and championed the cause for involvement in the local ISPE happenings.  Did someone mention golf?

Left to right: Dr. Carolyn Hsu, Michael Levesque, Joshua Froimson (Abbott), Dr. Arthur Shaw, Dr. William P. Beierschmitt

Next, Joshua Froimson presented an overview of the Abbott Bioresearch Center, and Abbott as a whole.  Carolyn Hsu gave some additional opening remarks, then introduced the guest speakers: Arthur Shaw, PhD, consultant to ELSIE, and William P. Beierschmitt, PhD, of Pfizer.

Dr. Shaw presented an overview of the ELSIE, including its background and purpose.  ELSIE is a consortium of pharmaceutical, biotech, and medical device companies that is developing a database that will hold safety information on extractables and leachables from a variety of materials; and controlled extraction study information from materials used in container closure systems, devices and bioprocessing. Currently, the ELSIE consortium is composed of Abbott, AstraZeneca, Baxter, Boehringer Ingelheim, Eli Lilly, GSK, Merck Serono, Novartis, Pfizer and sanofi-aventis.  All pharmaceutical, biotechnology and medical device companies are invited to join ELSIE. 

Left to right: Jason Nisler, Sam Fischer, Williiam Devine

Dr. Shaw noted that the primary objective of ELSIE is to provide standardized test protocols to generate extractables data for a wide variety of materials commonly used for container closure systems.  Additional work will ultimately be performed on in-process materials.  All of this data will be entered into the ELSIE Safety Information Database, from which it can be analyzed by toxicologists and reviewed for leachables study data.

Dr. Beierschmitt presented a demonstration of the ELSIE Safety Information Database.  This is a powerful tool that will enable companies to share important safety data regarding leachables and extractables, and will save untold resources in the coming years.

Following the presentations, a variety of attendee questions were answered by the panelists.  One notable closing thought was that the member companies of the ELSIE consortium have made the strategic determination that they are not in the business to compete based on safety, as any negative event is viewed as an industry-wide problem by the average consumer.  ELSIE is intended to allow companies to focus their resources on the safety of their drug substances, not their containers.









 

YP Event - Craft Beer Tasting - IPA's and Dopplebock's and Witbier, oh my!

by Jillian Willard, Genzyme

On June 8 ^th , more than 40 young professionals came out for a craft beer tasting at Gordon's Fine Wines and Liquors in Waltham. The tasting took the YP's around the world, as fifteen craft beers were poured, representing some of the best offerings from the US, Belgium, and Germany. From IPA's to Doppelbock's, each pour came from one of Gordon's three resident beer experts, who fielded questions from the crowd as they poured the heavenly nectars into eagerly awaiting hands holding tasting cups. The YP's left the event full of delicious and educational memories, with the additional pleasure of watching the Bruins rout the Canucks 4-0 on their way to winning the Stanley Cup. It was the perfect way to end a great evening.

Young Professionals Sampling Craft Beers

Young Professionals Corner

The Young Professionals wrapped up a year of successful events with our Craft Beer Tasting event on June 8 ^th . The great turnout was just another indicator of how much the group has grown over the past few years „Ÿ from a small group of young ISPE members huddled around a table with some drinks at a local bar in 2008, to the organized group that it is today, offering multiple educational and social events. Thanks to everyone who has made this growth possible, from Dan Ramsey (the maverick who started it all), to all of the YP committee members past and present who have made our programs possible and volunteered their time to make YP better. And thanks also to all of the board members who have supported our mission and been our biggest advocates.

This year the young professionals put on three educational events, sponsored both educational and social events at the product show, cruised the seas with Captain Mike of the Boston Belle, took on the "seasoned veterans" of ISPE in a softball game, came together for food, drinks, and billiards at Flat Top Johnny's, and in our grand finale for the year, enjoyed some craft beer at Gordon's Fine Wines and Liquors. We hope that everyone who attended these events enjoyed themselves, and we look forward to seeing everyone (plus hopefully some new faces) at our upcoming events in the fall. Keep your eyes open for announcements for our third annual boat cruise and a rematch of the YP's vs. Seasoned Vets softball game.

If you're interested in getting involved in the YP program as a committee member, or in getting more information about our events and what we do, please email office@ispeboston.org .

Hope to see you all soon!

Jillian Willard, Rob DeCoste, and the rest of the YP Committee.

11th Annual Ski Trip to Cannon Mountain

by Chris Opolski, Alexion Pharmaceuticals, with photos by the author

Chapter President Jim Grunwald presents the Golden Boot Award to Leighton Terwilliger for attending all eleven Chapter ski trips.

On March 4, 51 hearty souls braved an early morning start, boarded a bus and drove north to the White Mountains. The weather prognosticators called for blue skies and seasonal temperatures. What the group didn't realize was what "seasonable" meant in the North Country. Temperatures in the single digits and 20-plus mile per hour wind welcomed this sleepy bunch to Cannon Mountain in North New Hampshire.

Social Committee Member and event   organizer Gene Dennen gets some well-deserved rest on the bus ride home.

After getting off the bus and unpacking the ski equipment, tour guide for the day Gene Dennen passed out tickets and wished us all happy skiing. It was a typical day at Cannon, cold and windy with lots of snow. If you managed to find a part of the mountain not buffeted by strong winds the skiing was quite good. A lot of the group chose to ride the tram for the day since a little respite from the wind allowed blood to get back into our fingers and toes. 

After the long, cold day of skiing the entire group met at the Cannonball Pub to enjoy delicious appetizers and cold beverages. There was much socializing, meeting up with old friends or meeting new ones, and of course chatting about the skiing. Our President, Jim Grunwald, also presented an award to Leighton Terwilliger for having attended all 11 ISPE Boston Chapter Ski outings.

After a few stops for provisions, the bus headed south while the group enjoyed the movie Cannon Ball Run, which included a fine acting performance by Burt Reynolds. It was a long ride home back to Massachusetts (and, for some, Rhode Island) so a few took naps, especially our hard working group leader, Gene Dennen. A huge amount of thanks goes out to Gene for the great effort in organizing the event.  

See you on the slopes next year!

Members meet at the top of the mountain to commemorate yet another memorable Chapter ski trip.

The Chapter Scores Again with Bio-Ball Sponsorship  

by Sylvia Beaulieu, The Richmond Group

As Chapter Past President and Bio-Ball Committee member, I am very pleased to say that once again ISPE helped our community by giving back in time and financial support to Bio-Ball. I would personally like to thank all the ISPE Boston Area Chapter Members who came out to support Bio-Ball on Friday for set-up and Saturday for the day of the event.

Hundreds of enthusiastic participants and spectators crowded the stands for Bio-Ball 2011.

Bio-Ball is a one day basketball tournament involving 16 local biotech and pharma companies and 16 Special Olympics basketball teams. The event is sponsored by all of the providers that support the local biotech community with all of the proceeds going to benefit basketball programs and activities at Special Olympics Massachusetts. This was their seventh year and they had the biggest crowd ever - over 500 participants! More importantly, this year Bio-Ball gave a check for $88,000 to Special Olympics, bringing the total raised in the event's seven-year history to over $500,000.

The Bio-Ball tournament was held on Saturday, March 26 at the Buckingham Browne & Nichols School in Cambridge. Participating industry teams included Agios, Alnylam, AMAG, AVEO, Cubist, Genzyme, Infinity, Ironwood, Momenta, Novartis, PAREXEL, Shire, Sunovion,Vertex, Zalicus and MassBio.

Again this year, the Boston Area Chapter sponsored the CEO Free Throw, one of the tournament's most popular events. Chapter President Jim Grunwald was front and center to congratulate each free throw participant and hand them a small gift on behalf of the Chapter - a whistle with an ISPE lanyard.

Chapter Past President Sylvia Beaulieu (front, right) with CEO Free Throw participants.

For those keeping score, Momenta came out on top in tournament play over Genzyme, but everyone was a winner - particularly the Special Olympics athletes with their hard work and determination - and all who participated and experienced their spirit, joy, and enthusiasm. Hope to see everyone there again next year!

Chapter Brainstorming Sessions Target Educational Program Topics

by Brian Hagopian, Mar Cor Purification

No matter how smart you think you are, there is always more to learn, particularly in this industry. As part of our effort to bring new and innovative educational programs to our members, the Boston Area Chapter recently sought out ideas from our membership on topics of interest in order to formulate plans for educational programs for the coming program year. Involving interested members in the topic generation process would open dialog and introduce new topics to the Chapter's educational mix.

First, we started with our Certified Pharmaceutical Industry Professional   ^TM   (CPIP   ^TM   ) Study Group, where about 30 dedicated pharmaceutical professionals were involved in a multi-week study group designed to prepare them for ISPE's CPIP certification process. The group took time from their preparations and openly shared their ideas and thoughts about programs that would be of value to them. Next, we opened this brainstorming process to everyone and invited the entire Chapter membership to participate in an open session held at the Genzyme Center in Cambridge. This session was filled with interested industry professionals and resulted in a lively session.

Frankly, I was awestruck by the diversity of topics offered up by people who participated in these sessions. I heard about topics outside of my area of expertise and came away thoroughly impressed at the collective intellectual muscle that gathered to share their ideas and help the Chapter continue in its leadership role in the local industry and in ISPE. From facilities to validation, introductory to advanced topics, close to a hundred topics were suggested for consideration.

If you want your ideas heard but missed this part of the process, no worries. You still have time to voice your opinion and share your thoughts. We have a list and, as we work to fine tune it, we will need your help in vetting the list and selecting the topics of greatest interest so that we can plan ahead for the next program year and beyond. Please watch for our upcoming program survey and do take a few minutes to share your ideas and thoughts with us. The Boston Area Chapter is a great Chapter, but it is also your Chapter, so share your thoughts and help make it even better!

All Aboard! Next Stop INTERPHEX!

by Barry Potts, Automatech

I'm always surprised by the floating, comfortable ride afforded by a luxury bus on a highway trip. Such was the case with the recent bus ride we took to the INTERPHEX Show on March 29. For those of you who missed the show, it ran March 29-31 at the Javits Convention Center in New York City. Let's face it, getting to NYC can be an experience, but leaving the driving to someone else (and free of cost to ISPE members!) is a great way to get to this venue.

The bus left at 7:15am from the University Ave/Route 128 MBTA Station in Dedham. (We gave a few moments to those who would be running late). In total, there were thirty-three passengers who took the bus down on the first day at the show. After a stop at a McDonalds on the Connecticut Turnpike, we arrived in NYC at approximately noontime, right by the doors to the Javits Center.

INTERPHEX was what you'd expect from the number and quality of exhibitors that were present, namely a well executed and impressive array of products and technologies. The show was clearly well-attended, with more than 11,000 attendees able to browse a myriad of exhibitor's products and services, including facilities products, packaging machinery, automation & control systems, and laboratory products, to name only a few. More than 500 exhibitors were present at the show, and many of my fellow bus passengers remarked at how large the show was.

The bus return time was set at 6pm, which gave us all ample time to walk the show, attend a conference or two, and have lunch at the Javits Center, or to walk a few blocks and experience some great nearby restaurants. As we settled in for the ride back to Boston, we all agreed it was a trouble-free way to get to the show and back and another great ISPE member benefit. I'd highly recommend it for anyone interested in attending INTERPHEX next year.

 

Boston Hosts 4th Annual ISPE Northeast Regional Student Leadership Career Forum

by Dave Novak, Novak Associates, Co-chair, Northeast Regional SLCF Committee

On Saturday, April 2, ISPE Student Members from Stevens Institute of Technology, University of Massachusetts, Villanova University, Northeastern University, Rutgers University and Worcester Polytechnic University assembled at the Royal Sonesta Hotel in Cambridge for the 4th Annual ISPE Northeast Regional Student Leadership Career Forum. 

UMass Amherst attendees Jennifer Duffy and Brody Stara (background) also served as hosts for the event.

 

The Forum, a joint effort of the Boston Area, Delaware Valley, New England and New Jersey Chapters, is a full day workshop providing insights on careers in the pharmaceutical, biotech and manufacturing industry where an exchange of information, ideas and lessons are shared among attendees and industry professionals. The day offered a series of formal presentations combined with many opportunities for attendees to network with other attending professionals and to follow up with the speakers concerning their personal and career goals.

The conference began with a personal view of ISPE by our current Chapter President, Jim Grunwald, followed by Robert Lechich, CPIP, Past President of the New Jersey Chapter. Brody Stara and Jennifer Duffy of the UMASS Amherst Student Chapter were the hosts for the event and provided the speaker introductions for the majority of the day.

 

The first presentation of the day was "Empowerment 101 - Skills and Techniques for a Stellar First Impression" by Dave Novak of Novak Associates and ISPE Boston Area Chapter Past President. The presentation focused on sharpening observation and critical thinking skills, and the practice of social etiquette. Attendees learned techniques for networking, proper hand shaking, business cards and dining etiquette, the elevator speech, interview tips, body language, and also explored the generation/cultural gap now occurring in the workplace. This presentation was followed by a mock interview staged by UMASS Amherst students to illustrate how students seeking careers in the pharmaceutical/biotechnology industry should conduct themselves at an interview, concluding with an interactive Q & A session and additional advice for successful interviews.

 

Bob Lechich of Pfizer explained that career planning begins with an assessment of one’s accomplishments, skills, and education.

 The first keynote speaker for the event was Jim Breen, Vice President of Project Management in Johnson & Johnson's Worldwide Engineering and Technical Operations Group and current President of the New Jersey Chapter. Jim discussed his own career, using it as an example of challenges faced and accomplishments achieved. He also shared a global perspective of the pharmaceutical and biotech industry and the challenges that are ahead for engineers in the world marketplace. The second keynote speaker, Rick Pierro, President of Superior Controls and ISPE Boston Area Chapter Past President, provided his career story as an entrepreneurial adventure, highlighting the sacrifices, challenges, and decisions he made during the early stages of his career that led to his company's success in the biotech and pharmaceutical industry.

 The afternoon sessions began with a presentation on career planning by Bob Lechich, CPIP, Director of Operational Excellence in the Global External Supply Organization at Pfizer and Past President of the New Jersey Chapter. Bob discussed the annual assessment of one's career, which involves a self-evaluation of accomplishments. Taking this annual review provides the ability to model your skills and education goals against new demands and future requirements for the biotech/pharmaceutical industry. Following a break, Meagan Driscoll, President of PharmaLogics Recruiting, provided an interactive session on the best resume format, the do's and don'ts of social and electronic networking, the best ways to apply for a job and great insights on preparing for an interview.

 Members of our Young Professionals/Student Members also provided insights on their careers and described how ISPE offers a great foundation of resources, networks and opportunities that supports career growth. Included were talks by Dan Ramsey of Commissioning Agents and the Boston Area Chapter Board of Directors; Archana Sidalaghatta Nagaraja of the Delaware Valley Chapter and an ISPE International Graduate Poster Contest Winner; and Rosemary Garofalo of Stevens Institute of Technology Student Chapter and also an International Student Poster Contest Winner, in the Undergraduate Category.

 As the day came to a close and many of the participants lingered to make that one final connection or obtain a business card from a mentor or speaker, I found myself reflecting on the efforts of the multi-Chapter committee that has worked so diligently to organize this annual event for the past four years: Did we do a good job? Was it a great event? Were the techniques helpful? Will the attendees be able to use what they have learned? Just then one of the students stopped to speak with me on his way out of the room. He thanked me for my time and effort and added, "Today I have learned many skills that will not only help me in gaining a job, but will continue with me for the rest of my life." Well I got my answer!

 Many thanks to the ISPE Boston Area, Delaware Valley, and New Jersey Chapters, especially members of the joint committee: Bob Lechich, CPIP, Joe Manfredi, Nancy Tomoney , Chuck Clerecuzio, CPIP, William Dugary, Alex Meyers, Jennifer Duffy, Brody Stara, Jim Grunwald, and Committee Co-Chair Dan Ramsey, whose efforts and support made this event possible.

  

Young Professionals Deliver the Basics on Clean-in-Place Systems

    by Josh Strauss,   Commissioning Agents with photos by the author    

 The ISPE Young Professionals group was formed to meet the professional needs of individuals who are establishing their careers in the biotech and pharma industries. Lou Traglia from Commissioning Agents delivered the Young Professionals' April educational program at Genzyme in Cambridge on the fundamentals of CIP function and design. Lou captivated the audience with down-to-earth examples of why we spent all those sober Friday evenings in college studying mind-blowing topics such as the Reynolds number and conductivity.

 

The Genzyme Center auditorium provides an impressive backdrop for the YP educational program on CIP fundamentals.

 Referencing the parameters of TACT (Time, Action, Concentration, Temperature), Lou designed for the audience the standard CIP layout and detailed the utilities and vendor chemicals used in the industry and their purposes, mainly CIP 100 and CIP 200. Having delivered the advertised material, Lou wrapped up the evening demonstrating common pitfalls in CIP design and function.

 Lou's presentation taught valuable lessons to both new and experienced engineers in the audience. As it turns out, conducting slope verifications and eliminating dead legs are essential for validating CIP cycles! The evening was very educational, entertaining, and engaging for the audience. On behalf of all members of the Young Professionals, we thank Lou for his excellent presentation.

Panelists from BMS, Genzyme, Pfizer & MassBiologics Shed Light on Risk-Based C&Q

by Jack Campion, Genzyme with photos by Joyce Chiu, CPIP, Sperian Protection

Genzyme Science Center in Framingham was the site of the Boston Area Chapter's February 17th educational program. The title of the program was "Panel Discussion: Risk-Based Commissioning and Qualification." This is a hot topic in the industry currently as firms adopt the ASTM E2500 standard as well as other risk-based standards and guidance to their commissioning and qualification (C&Q) programs.

An overflow crowd enjoys the networking reception prior to the panel discussion.

The meeting was co-chaired by Jack Campion, validation manager for purification and fill finish at Genzyme, Allston; and Aaron Jordan, IT Validation Manager at MassBiologics (UMass Medical). The meeting was moderated by Jack who also serves as co-chair of the Educational Programs Committee (EPC) for the Chapter.

The wide interest in this topic was demonstrated by the nearly 100 who registered to learn both from the panelists and each other. Three panelists, all Members of the Boston Area Chapter, generously shared their experience, giving the audience members several perspectives on the topic, with short slide presentations followed by audience participation. The three panelists were Armen Nahabedian (Director, Commissioning/Qualification, Pfizer Global Engineering), Michelle Whipple (Associate Director of QA Validation, Bristol Myers-Squibb, Devens) and Eric Felz (Validation Manager, Genzyme, Framingham). All three panelists are Members of ISPE's C&Q Community of Practice (COP) Owner's Task Team.

The first presentation was given by Armen Nahabedian. Armen co-leads the development and roll out of the Pfizer Verification Program. Armen gave the "global enterprise" perspective, describing the differences in "adoption" by various Pfizer sites world-wide. Some are early adopters, embracing the risk-based concept broadly. For others, it is more practical to choose one project as a "pilot" for application of the risk-based approach. Armen also debunked several myths about the risk-based approach, such as the notion that "verification" means less testing. In fact, verification is "sufficient testing to show fitness for use," which may mean more or less testing than previously, depending on the associated risk.

 

Education Program Committee chair Jack Campion (l) with panelists (l to r) Armen Nahabedian, Steven Wisniewski, Michelle Whipple and Eric Felz.

Michelle Whipple of Bristol Myers-Squibb (BMS) told the audience how the risk-based approach was applied to the new BMS biotech plant at Devens. Michelle provided details of the process by which systems and equipment were assessed for their risk to patient safety. She described how 85 systems were subjected to a three-stage assessment over two months after the process design was complete. Onsite testing requirements for each system depended upon the extent of vendor documentation, factory acceptance testing already performed, complexity and risk.

Eric Felz told "A Tale of Two Projects," two nearly identical projects involving replacement of air handling units in separate buildings. In both cases, the units and the associated cleanrooms were in scope. However, in one, the traditional approach of commissioning followed by qualification was applied. In the other, a more integrated and risk-based approach was employed. In the risk-based case, Eric described how the Critical Quality Attributes (CQAs) were identified and associated with Critical Process Parameters (CPPs). Risks to patient safety were evaluated. When compared, the two methods showed some startling differences. The risk-based approach excluded a significant amount of what we traditionally include in validation, such as installation qualification (IQ) of all air handler (AH) components. Instead, the risk-based approach commissioned the AH, treating it as an upstream utility, and did not subject it to formal IQ. Only five key physical parameters and their associated equipment and controls required formal validation: HEPA certifications, room temperature, room differential pressures, air flow, and duct static pressure.

After the presentations, audience members asked questions about the relationship between "verification" and "validation," the panelists' experience with organizational resistance to change and a range of other topics. Attendees also received a "bonus" afforded by the attendance of Steve Wisniewski, former ISPE Chairman and founder of the C&Q Community of Practice. Steve, who is with CAI and on assignment at Genzyme, gave the audience a preview of the upcoming ISPE "practice guide" to help make the transition from traditional C&Q to a risk-based approach.

Participants all received a hefty helping of take-home information that will pay dividends as they apply them to real, everyday projects in the pharma industry.

Career Transformations: Capitalizing on Your Transferable Skills

by Dan Gee, Biotech Drug Development Consultant

Along with the rest of the country, the biopharmaceutical industry has been feeling the ramifications of the Great Recession for the last few years. As a result, industry professionals have found themselves in transition and wondering about their careers and the future. For many it's more than just getting another job. It's how to leverage the valuable skills they have honed during the course of their careers while keeping their personal interests/family and ambitions in the proper perspective.

To identify the issues and provide a strategy and plan that industry professionals can apply to their specific situation, an interactive program was presented by the Member Services Committee on February 10th at the Regus Business Center in Newton. The meeting was moderated by Committee Members Ric Feldt and Bob Urbanowski in a format that consisted of an interactive discussion with audience participation and two panels, each consisting of a professional Career Coach/Counselor and several industry professionals who have capitalized on their skills and made a career transition.

The focus of the first panel was entrepreneurs/small business owners who have departed from traditional employment to pursue entrepreneurial ventures or have become business owners. Panelists were Suzanne Gray (Self Employment Coach, The Entrepreneur's Source), Peter Antoinette (President & CEO, Nanocomp Technologies), Dr. Elizabeth Higgins (President and Founder, GlycoSolutions); and Michelle Connor (Owner, AdviCoach). The second panel was composed of professionals who have leveraged their skills and career experience to work in a different function or industry: Fred Nothnagel (Executive Director/Owner, Wednesday Is Networking Day); Shelly Henderson (Life Sciences Business Development), and Christine Gebski (Director, Applications and R&D, POROS Chromatography Resins, LIFE Technologies).

The career coaches used their specialized expertise to facilitate discussion about the soft skills, planning processes, personality profiles and values typically required for success and added their own success stories to the mix, while the distinguished panelists described what they did to be successful in their chosen careers and added personal insights gained from lessons learned along the way.

The following are a few of the questions used to frame the discussion and some of the panelists' responses:

• Identifying Your Work/Life Goals. What are key questions to ask yourself when considering making a change? How do you know if a specific function, industry or business is right for you? If you were starting out in your career, what would you choose to do and why?
  Identify what your work and family life will look like in the future and the legacy that you want to leave. This will lead to your goals, plan and specific career/business opportunities. In other words, "avoid being a cork floating down the river and take control - add a motor." Also consider "What do you want less of?"
• Factors to Consider. What is the profile of a successful transitioner/business owner?
  What personal values and abilities do you consider to be important? A key strategy is to "review your accomplishments - this will point to the skills that have made you successful so you can play to your strengths." Also "take off your blinders, try looking at the world in a different way" and "don't listen to too many advisors." Another piece of advice was to fully assess your skills and "get an inventory such as through Myers-Briggs or DISC."
• Assistance Sources. What are the most important questions, and what are the best information sources for answers?
  Why are informational interviews valuable? Should you enlist the support of friends and family? The panel advised attendees to network in work and social circles and to "surround yourself with a board of advisors, formal (legal, etc.) and informal (friends, ex-colleagues, networking contacts)." For financial support, one entrepreneur recommended taking advantage of "business incubator funding that is available."
• Pathways. What knowledge and experience is applicable for a smooth transition into a different market? What are the current biopharma "extension or spinoff" technologies and industries offering a promising future? What are the steps to develop a product or service based on your idea?
  One panelist advised, "maintain your mental fortitude by keeping a positive attitude" and "believe in yourself." Another said "skills can be taught, attitude must be innate." Another advised, "avoid naysayers - ‘the crabs in a basket' - who pull you down with negativity."

In summary this was a very challenging topic to cover in such a short period of time and only the surface has been touched. There was enthusiastic audience participation and opportunities to network before and after the session. Nevertheless, the meeting provided a catalyst for attendees to begin pondering the many questions and answers discussed in the context of their own career and personal life. As a final take home message, these fundamental questions should be reevaluated regularly to help you to stay "on course," not just during hard economic times.

First “Dual-Track” Educational Program Proves Popular with Members

In a "first" for the Boston Area Chapter, the Educational Program Committee partnered with the Young Professionals Committee to present a "dual track" educational program on January 20th at the Hyatt Regency in Cambridge. The dual-track approach was chosen to provide concurrent presentations on the same general topic - in this case, process automation and control, with each presentation geared to a different level of audience expertise. "Introduction to Automation in Life Sciences" was designed for those new to the field and "Advanced Process Control for Greater Profitability" for those who had already mastered the basics. Combined networking receptions before and after the presentations allowed both groups to meet, mingle and compare notes. This approach proved so successful that it is sure to be repeated in the future.

Introduction to Automation in Life Sciences

by Tim Schmidt, New England Controls with photos by Joyce Chiu, CPIP, Sperian Protection

Whether dealing with validation, manufacturing, R&D or other operational tasks, engineers are asked to leverage automated systems to meet the challenges before them. Understanding the terminology, fundamentals, and integration of these systems can be a daunting and difficult task. Compounding this effort is the rapid growth of automation technology on multiple platforms resulting in an abundance of information. All of this can overwhelm even the most attentive domain expert in a short amount of time.

To demystify the fundamentals of process automation, the Young Professionals developed the evening's introductory program. Young (and young at heart) attendees packed the room to hear Tim Alosi of New England Controls walk through the basics of automation technology while taking time to discuss questions and share his experiences.

Speaker Tim Alosi proves the value of a hands-on demo.

Tim started with the fundamentals of a controlled feedback loop, progressed into the essential hardware architectures and wrapped up with a high-level view of applied strategies. Of particular interest was his perspective that today's automation platforms are equally capable of performing elementary process control on a variety of scales. Differentiation does exist but is now found in specialized areas. He also presented the concept of an automation life cycle which need not be limited to capital projects but can be applied to smaller projects as engineers positively impact their process.

To finish with a bang (or a hiss), the audience asked Tim to put the laser pointer down and take a hands-on approach to create a working loop with controller, pneumatic valve, and pressure feedback device. It took him a matter of seconds to demonstrate all of the fundamentals covered in our session. In fact, many attendees stayed after to build their own loop and ask more detailed questions. Perhaps automation isn't so daunting after all!

Advanced Process Control for Greater Profitability

by Paul Doherty, CRB Consulting Engineers and Rami Mitri, Spectra Automation with photos by Joyce Chiu, CPIP, Sperian Protection

If there is one conclusion that can be drawn from this presentation, it is that the biotech field is full of innovative people. People like James Heimbach, who readily adapted new processes in order to achieve optimal results when standard control systems lack the depth to predict output based on data that is within its system

When Mr. Heimbach, a statistician for Lonza, was asked how he moved into the biotech field, given that his background was not in the industry, his response was that he created his own job. Drawing on lessons he had learned from a previous boss that were cutting edge, he understood the benefit of thinking outside the box. He believed that by bringing this kind of innovative thinking to the biotech field, he could achieve a competitive edge for Lonza.

Dual presentations offered attendees a choice of material - introductory or advanced.

The inspiration for this presentation was the partnership that was created at Lonza between Mr. Heimbach and Joseph Kauten, Director of Process Control. The result of this partnership was the concept that, by combining statistical analysis with process control, you could create a new breed of enhanced control systems.

An enthusiastic crowd was on hand to learn about Lonza's experience with "advanced" methods in controlling critical process attributes. The discussion included the use of neural networks to control titration, linear regression methods to predict harvest timing and feeding regimens, as well as Multivariate Process Control. Another key discussion point was integration of these techniques into a validated and tightly controlled automation system

One of the driving factors behind this concept was that Lonza, being a contract manufacturing company, needed to achieve a competitive edge in an industry that was moving towards commoditization. Lonza's clients needed ways to achieve higher throughput, derive more information from each batch and reduce variability so that their "time to market" would be faster than that of their competitors.

Data mining and data analysis was one way that Lonza answered their client's needs. Applying advanced control to various processes allowed Lonza to predict throughput and achieve consistent results, bringing every batch as close to the "golden batch" as possible.

Finally, Mr. Kauten discussed how advanced control in a highly regulated industry can be achieved with proper training as well as understanding cause and effect. As the two speakers demonstrated, applying advanced control, using off-the-shelf software that performs data analysis and provides concrete data, allows control system operators to refine their control schemes and achieve optimal results.

New Year's Social Raises $2600 for “Helping Our Troops”

by Michelle Greaney, Vanderweil P&IDC with photos by Joyce Chiu, CPIP, Sperian Protection

Volunteer Michelle Greaney congratulates lucky raffle winner.

History repeated itself on January 13th when the Boston Area Chapter once again congregated at Flat Top Johnny's Billiards in Kendall Square for our annual New Year's Social. Members and guests ventured out to into the cold to have some fun, meet with friends and colleagues, play some pool, enjoy great food and conversation and hope for a winning ticket so they could take home one of the many amfazing raffle items donated by our sponsors. Even a major snowstorm the day before didn't deter attendees, with close to 100 members and guests braving the slippery sidewalks and piled-high snowdrifts to join the fun. A diverse group of Chapter members made for lively conversation, with operating companies, academic and research institutions, vendors and contractors all well represented.

Happy faces were the norm at January's successful New Year's Social.

According to tradition, there was also a serious side to the event which was a benefit for Helping Our Troops (or H.O.T.), a local nonprofit based in Stoneham dedicated to helping soldiers from Massachusetts serving in Iraq and Afghanistan. H.O.T. has a program called "Adopt-A-Box" that provides soldiers with care packages filled with goodies - everything from phone cards, to tooth brushes and toothpaste, to beef jerky and beanie babies. You name it, any small item that can be shipped has been requested by our troops to help brighten their day, week - or even month!

The most moving portion of the evening came

Volunteer Gene Dennen gets thanks from Chapter President Jim Grunwald.

when H.O.T. founder and Vietnam vet Frank Geary described his organization, how it came about and its importance to our troops, followed by the proverbial "pin-dropping" moment when Sgt. John F. O'Riordan described how valuable seemingly small gifts can be. In one case, giving a beanie baby to a local child helped a truckload of soldiers find a route safe from ambush; in another case, a child led soldiers to a cache of weapons in return for a handful of beanie babies. The stories were amazing and the room grew silent as we all listened and appreciated anew our safety and security and the part played by the efforts of the brave Massachusetts men and women served by H.O.T. The message was received loud and clear - so clearly in fact that we exceeded our fund-raising goal and collected over $2,600 which will provide over 220 care packages for our troops. On behalf of the Social Committee and the Boston Area Chapter, thank you very much for your generous support.

Helping Our Troops representatives with Social Committee Chair & Board Member Chris Opolski.

None of this success would have been possible without the efforts of the Social Committee, specifically, Carly Star who designed the Sponsor profiles, Paul Sullivan who assisted with additional fundraising efforts and Committee Chair Chris Opolski who coordinated our team (with help from yours truly); and Hannah and Julia from the Chapter's admin group who greeted Members and guests and efficiently managed registration. And last, but certainly not least, our exceptionally generous sponsors: R.W. Sullivan Engineering; Superior Controls; SciTech Builders; Entertainment Cruises - Odyssey Cruises | Spirit Cruises | Elite Yacht Charters; The Richmond Group; CRB Consulting Engineers; Spectra Automation; and Columbia Construction.

 

YP Educational Event on Chromatography and Project Management a Hit

by Jillian Willard, Genzyme, with photos by Aarash Navabi, Genzyme

On November 17th, young and seasoned professionals alike came out to Genzyme Center in Kendall Square to attend an educational event on Chromatography and Project Management. Angela Lewandowski, PhD, from Genzyme's Purification Development group started the night off with a presentation on Chromatographic Protein Purification. She discussed the basics of chromatography, possible issues seen in scale-up of chromatographic processes and the major factors to consider when developing chromatography steps. Former Boston Area Chapter President Niall Johnson followed with a Crash Course on Project Management. With only 60 minutes to present, Niall was able to squeeze in an overview of the basics of project management, the main causes of project failures, what makes a great project manager, the major challenges faced by project managers, the elements of a successful project and the pitfalls to avoid.

Niall Johnson describes the trials & tribulations of Project Management to a rapt audience of young professionals at Genzyme Center in Cambridge.

The event had record attendance for a YP educational event, with more than 75 people packed into the lecture hall at Genzyme Center to hear two excellent presentations from experts in their respective fields. Keep your eyes open for announcements of our educational event in January on the topic of automation. This will be a good first look into what automation is and how it is influencing our industry. Hope to see you all then!

Young Professionals Brave Cold to Attend Winter Social

by Marjorie Bruce, Capaccio Environmental Engineering

On the first Tuesday of December the Boston Area Young Professionals held a Winter Social at Flat Top Johnny's in Kendall Square to kick off the holidays. Many young professionals braved the first real cold snap of winter to play pool, eat good food, and network. The goal of this event was to bring new faces out to ISPE and show them some of the benefits of the YP group and it definitely accomplished its goal.

The Winter Social began at 7pm and the pool tables served as an excellent ice breaker to begin conversations. By the end of the night, everyone was deep in discussion with pool forgotten, as people exchanged business cards and ideas. All the attendees were able to mingle and talk with members of the YP committee to learn about our goals for the upcoming year as well as events taking place in the near future. Several attendees expressed interest in joining the YP committee, which is always in need of volunteers.

Keep your eyes open for announcements about our next social in early February - details to be announced. We are particularly interested in reaching out more effectively to area students and plan to hold an event especially for them in the near future as well. We welcome any ideas and suggestions for future events! If you have any ideas or feedback, please don't hesitate to email us at ispe@camihq.com. We look forward to hearing from you!

EMD Serono Hosts Facility Tour & High Purity Water Panel Discussion

by Sean Brown, Lantheus Medical Imaging, and Brian Hagopian, Mar Cor Purification, with photos by Joyce Chiu, CPIP, Honeywell Safety Products

The Boston Area Chapter participated in an exciting tour of EMD Serono's Project Unity in Billerica on December 9th. It was clear from the start that this was an extraordinary location for the Hot Topics in High Purity Water discussion that followed the tour. The event began in the early evening on a bitterly cold New England day, with flurries possibly giving way to winter weather. Although this might have meant a dropoff in attendance, the weather was not a factor for this sold-out educational event due to the spectacular venue and intriguing presentation.

The audience was filled with people from across New England who traveled to see this magnificent project. The event started out with a networking social sponsored by Jones Lang LaSalle prior to the departure of several "flights" piloted by a team of tour guides from the Facilities Management group. The venue provided insights into the cutting edge technologies utilized throughout the project to create an energy efficient and sustainable facility to support EMD Serono's quest to address "unmet" medical needs.

Lucky Members get a behind-the-scenes look at EMD Serono's newly completed research center.

Tony Meenaghan, EMD Serono Senior Director of Facilities Management and Engineering, EHS, followed with an informative overview of Project Unity, the culmination of the strategy to create a global research presence in the US. Project Unity creates a modern, collaborative environment by bringing Technical Operations and Research together under one roof - a 140,000 square foot research facility that will ultimately achieve LEED gold certification. Coincidently, the date of our visit was also the official Project Unity completion date!

Tony provided a colorful overview of the project from inception to occupancy, as well as a passionate description of the value this investment will provide to the healthcare and patient community. He then passed the baton to Alan Ames, President at BR+A who provided a deep dive into the project programming and the significant features of this unique facility, including the sustainable energy savings infrastructure, that will position EMD Serono to reap its benefits well into the future.

The tour and Project Unity presentations were followed by a standing room only discussion on Hot Topics in High Purity Water which was moderated by Boston Area Chapter Vice President, Brian Hagopian of Mar Cor Purification. The panelists were a mix of suppliers and end users with local, national and international experience, and represented yet another example of the quality of speakers the Chapter is able to attract. At the beginning of the session, attendees were encouraged to join the ISPE critical utilities community of practice (COP) to keep up to date on the topic of high purity water.

Attendees included Student Members from the Student Chapter soon to be formed at WPI.

The panelists demonstrated their thorough knowledge of the subject matter and responded to a wide range of complex questions posed by the audience during the lively and interactive session that followed. Audience questions covered a broad spectrum of topics, including the effect of water supplies on water treatment processes, water treatment performed by municipalities (particularly the MWRA) before the water even reaches our buildings, and effective methods of chlorine/chloramine removal along with symptoms and corrective actions associated with ammonia. A few audience members volunteered their experiences by offering suggestions on treatment, detection, and monitoring techniques they have used successfully. 

Attention next turned to the subject of biofilm, where the panelists drew distinctions between biofilm (and the bacteria that create biofilm) upstream and downstream of a reverse osmosis (RO) system. And what would a pure water session be without discussion on the topics of validation and rouge? Panelists shared their experiences on "breaking into" a validated system to extend piping loops to new areas and the validation impact of such changes.

As for rouge, many of you know rouge is prevalent in heated WFI and some USP systems and it was postulated that the presence of carbon dioxide may accelerate rouge formation. Panelists discussed the different types of rouge along with detection methods and how to determine when to plan a shutdown to remove rouge. The pros and cons of risk-based approaches were examined and compared against planned shutdowns where multiple activities such as calibrations, gasket changes, etc. could be combined for cost effectiveness.

Moderator Brian Hagopian (center) with "high purity water" panelists (l to r) Christopher Corsetti, Bob Livingston, Anthony Bevilacqua, Rick Kotosky.

There was such a high level of interest in the topic of rouge that we have planned a follow up technical article in an upcoming issue of this newsletter. And because of the importance of pure water to our industry as demonstrated by the turnout and lively discussion at this event, members can expect to see more coverage of water purification topics in future newsletters and educational programs.

This expert panel provided great insight and practical knowledge during the panel discussion. Our sincere thanks go to Anthony Bevilacqua (Mettler-Toledo Thornton), Christopher Corsetti (Genzyme), Bob Livingston (Arion Water) and Rich Kotosky (Organogenesis) for their time and valuable contributions to the success of this event.

“Negotiation for Success” Workshop Provides Useful Insights

by Barry Potts, AutomaTech with photos by Joyce Chiu, CPIP, Honeywell Safety Products

Have you ever hoped to better understand and practice negotiation skills and principles that would help in your business and personal lives, in your daily interactions with clients, co-workers, family members, friends and neighbors? Learning how to uncover underlying interests and mutually beneficial opportunities to create win-win solutions in even the toughest negotiating situations was the subject of the workshop presented by the Member Services Committee, on the evening of November the 3rd at the Elephant & Castle Pub and Restaurant in Boston.

Chapter Board Member Steven Kennedy (far r) chats with workshop participants (l to r)  Dan Gee and Robert Fortier.

The instructor for this session was D. Mark Fourman of Unify Consulting, a respected consultant specializing in conflict resolution and alliance management. Since 1992 Mark has trained and coached staff from the boardroom to the bench in leading biopharmaceutical companies such as GlaxoSmithKline, Roche and Genentech as well as many smaller biotechs.

This highly interactive workshop involved role playing activities of 5 to 15 minutes each in a fun and engaging environment with four small breakout groups, each with their own whiteboard, all trying to brainstorm and figure out compromises, solutions, etc. based on a scenario that needed to be negotiated. Case studies and workshop exercises ran the gamut, ranging from a business situation involving two companies negotiating to support a new product launch in a threatened economy, to everyday situations that can occur in one's own neighborhood. This all made for a relaxed atmosphere where ISPE members as well as non-members were able to meet with friends and foster new relationships while learning new skills or polishing an existing skill-set.

Role playing activities in small breakout groups resulted in immediate camaraderie amoung participants. Pictured: John Vital, Chris Coughlin, Julieann Dickerman and Karen Snyder.

Mark pointed out that these principles - uncovering underlying interests and mutually beneficial opportunities to create win-win solutions - have even been applied to resolve situations involving international political relationships. While most of us won't be negotiating on such a grand scale, learning and understanding the steps behind successful preparation and negotiation can be very helpful. In fact, a couple of workshop attendees reported back that they were able to make use of what they had learned the very next day!

ISPE Annual Meeting & Student Poster Contest - A Winning Combination

by Sheba Goklany, PhD Candidate, Northeastern University with photos by Teo Zi Qiang, PhD Candidate, Nanyang Technological University

With its beautiful tropical weather and Disney's largest creation, Orlando was the perfect getaway destination from Boston. My friend and I, representing Northeastern University, were headed there for the ISPE Annual Meeting and Student Poster Contest. We arrived in Orlando on Saturday. We were staying at the Disney Swan and Dolphin Resort, which was also the venue for the meeting. During our stay there, we got an opportunity to wander around the world-famous Disney World. We also had the chance to explore Epcot, showcasing different parts of the world such as Canada, United Kingdom, and China, and Disney's Hollywood Studios, presenting the "Spectacle of Dancing Lights." The atmosphere in Orlando was one of sheer magic.

Proud winner Sheba Goklany (center, front) of Northeastern University with fellow students following the Awards Luncheon at the ISPE Annual Meeting in Orlando.

For us, the Annual Meeting kicked off on Sunday with a luncheon hosted by the Young Professionals. This was a networking event to gather the undergraduate and graduate students from all over the world participating in the Poster Contest, including those from Singapore and Turkey. This event also focused on connecting with young professionals in the biotech industry who were more than happy to mentor us and encouraged us to provide feedback to help make ISPE more beneficial for its young members. Never before have I seen such involvement and commitment on the part of members of a professional organization in an effort to help students by sharing their experiences, knowledge, and support and by guiding them through their academic and professional careers.

Besides learning about the different aspects of the biotech industry, the ISPE meeting was a great place to meet, network, and make new friends. Events included keynote sessions, presentations from several industry leaders, product exhibits, networking breakfasts/dinners, and even a 5K walk/run for the fitness-conscious. In addition, each local Chapter had organized an exclusive social event for its members. The Boston Area Chapter had arranged cocktails and dessert on Sunday night giving all of us the opportunity to mingle with the locals in the Boston area biotech industry.

The Poster Contest was on Monday afternoon. I remember practicing my talk just prior to the competition. I think the biggest challenge for me was to fit my presentation into the five-minutes allotted to each presenter. Even though I was nervous, I was happy that I had the opportunity to compete at the international level and also to interact with and learn from so many ISPE members. At the awards ceremony I was surprised and overjoyed when my name was called out as the winner of the graduate-level competition. To receive the award in front of thousands of leaders from the industry was truly a humbling experience and a privilege.

This was my first time at the ISPE Annual Meeting and it was a great experience. My special thanks to Rick Pierro (President of Superior Controls), Kevin Lynch (Director of Manufacturing at Shire), Dr. Carolyn Lee-Parsons (my advisor at Northeastern University), and Hong Long (President of the ISPE Student Chapter at Northeastern University) for providing me with valuable feedback on my poster and for helping me prepare for this event. I am also grateful to the ISPE Boston Area Chapter for sponsoring our trip to Orlando and giving us this valuable opportunity to showcase our research and connect with people from the pharmaceutical industry worldwide. For those of you who ever get the chance of attending one of these ISPE meetings, I would say, "Go for it, it will be an event to remember and cherish for a long time to come."

Boston Area Chapter Hosts Japan Affiliate

by H. Steven Kennedy with photos by Shigeru Nakamura, Head of Secretariat, Japanese Affiliate

On November 1st, the Boston Area Chapter welcomed a group of 20 delegates from the Japan Affiliate to Boston as they passed through on their way to the ISPE Annual Meeting in Orlando. The Chapter's Board of Directors hosted a reception and dinner for the visitors at Legal Seafood in Cambridge. The event was co-coordinated between Shigeru Nakamura, Head of Secretariat for the Japanese Affiliate and myself on behalf of the Board of Directors.

Past President Sylvia Beaulieu and Japan Affiliate Member Masayuki Akutagawa enjoyed comparing notes over dinner.

The evening opened with the traditional Japanese toast - Kampai - followed by a presentation on the Chapter and its activities that I had prepared especially for this event. Nakamura-san followed with a reciprocal presentation about the Japan Affiliate. Nakamura-san concluded his presentation with an invitation to the Board to travel to Japan in the spring to help the Japanese affiliate celebrate their tenth anniversary. Discussions followed, exploring how the Boston Area Chapter can help support initiatives by the Japan Affiliate to expand their educational offerings in the area of biomanufacturing.

To bring the evening to a lively close, Nakamura-san led the new group of friends in Tejime - a Japanese custom of ceremonial rhythmic hand clapping performed at the end of a special event. The Japan Affiliate was invited to attend the Boston Area Chapter reception at the ISPE Annual Meeting and a few days later the group reconvened in Orlando, where the friendships forged over food and drink in Boston were strengthened further at (Boston's own) Todd English's restaurant, Blue Zoo.

Members Gather to Celebrate “Chapter of the Year” Repeat Win

 

Sometimes a photo is "worth a thousand words"...

by Janet Tice, GMP Piping, with photos by Joyce Chiu, CPIP, Honeywell Safety Products

In a repeat of last year's festivities, the Boston Area Chapter again gathered at the Sonesta in Cambridge to celebrate its big win at Annual Meeting. This time, the Chapter won the coveted Platinum Grand Award for Excellence and Innovation - for the second year in a row! In addition, the Chapter was honored with two additional awards: the Grand Award for Innovation in Member Services and the Grand Award for Innovation in Programs and Events. Finally, the International Student Poster Competition Award in the Graduate Category went to Sheba Goklany of Northeastern University, a Boston Area Chapter student member.

 

 

 

Chapter Vice President Brian Hagopian and Product Show Committee Co-Chair Laurie Masiello helped the Chapter celebrate success.	Chapter Past-Presidents Sylvia Beaulieu (2010) and Doyle Johnson (2009) earned Chapter of the Year Awards two years in a row.

What better reason for a celebration to sing the Chapter's praises and thank the many volunteers who made this exciting win possible? And celebrate we did - with drinks, hors d'ouevres, a cake with icing proclaiming our win, and a thank you to Chapter volunteers and Members from 2010 Chapter President Sylvia Beaulieu, whose energy and creative vision helped cement our triple win. As the evening drew to a close, and with the new year fast approaching, current President Jim Grunwald took the floor and encouraged the crowd to work hard for another win in 2011. After all, three's a charm!

The Innovation in Member Services Award and the Member Services Committee whose efforts helped earn it: (l to r) Ric Feldt, Joyce Chiu, Chair Bob Urbanowski, Ann Engelkemeir and Barry Potts.

Crowds Brave Stormy Weather to Attend 19th Annual Product Show at Gillette

by Brian Hagopian, Mar Cor Purification with photos by Kent Van Vliet Photography

Over 270 exhibits greeted the 1800 who attended in spite of the stormy weather

Neither rain, hail, snow or sleet....well, you know how the rest of it goes. Not even torrential rain could slow down the momentum of the Boston Area Chapter's Product Show. The Chapter once again attracted a huge crowd to Gillette Stadium for the 19th Annual Product Show. The biopharm industry has begun its rebound from the recent economic downturn and growth was in evidence at this year's Show. The Boston Area Chapter, with its hard working volunteers, great Chapter management, supportive Board and enthusiastic vendor community, pulled off another tremendous Product Show.

Thanks to the hard work of a group of dedicated Chapter volunteers, the number of exhibitors was increased by about 10 percent and the Show was sold out well in advance, proving that our industry is showing growth and progress in this economic climate. With over 270 vendors exhibiting and over 1750 attendees buying, networking, and learning, industry know-how was hard at work.

Keynote speaker Dr Sylvie Gregoire of Shire HGT with Chapter Vice President Brian Hagopian (l) and Product Show Committee Chair Mark Sitkoske (r)

The Show's many featured activities helped draw attendees to Gillette, despite the inclement weather. Keynote speaker Dr. Sylvie Gregoire, president of Shire HGT, packed the house with her address describing Shire's products, technologies and plans for growth in Massachusetts. She was followed by a distinguished panel of Shire experts who provided in-depth, detailed answers to a number of wide-ranging questions posed by audience members. This industry-focused presentation with its unique local perspective proved to be winning formula that we hope to be able to repeat in upcoming years.

The Chapter again worked with the GAMP Community of Practice (COP) team for the third consecutive year to offer presentations before and during the Show. Participants were able to attend these sessions at Gillette and experience the Product Show during one action-packed day. And again this year, the Product Show Committee worked closely with the Young Professionals (now an official Chapter committee), who organized and coordinated two of the seven educational sessions presented during the day and joined Chapter Student Members at their traditional evening reception held in one of Gillette's luxury suites.

For those who came to learn, in

Opportunities for impromptu meetings are a Product Show plus

addition to the GAMP Forum and keynote address, the Show also hosted seven educational programs throughout the day. Many thanks to the presenters for the valuable information that they shared with attendees: Greg Ruklic, Theresa McCarthy from Pfizer, Kristin Murray from Pfizer, Randy Perez from Novartis, Stephen Reich from Pfizer, Dr. Carl Lawton from UMass Lowell, Dr. William Thomas from UMass Memorial Medical School, Dr. Michael Drues from Vascular Sciences, Gregory Zarbis-Papistoitsis from Percivia, Charles Pappalardo from Charles River Laboratories, Francis Boucher from National Grid, Paul Lukitsch from Millipore, Dan Wall from RDK Engineers and Steve Zilonis from Aricogen, Dresser-Rand.

For the second year running, the Chapter invited Karleen Kos, from the ISPE international headquarters in Tampa, to attend the Show, where she staffed the ISPE membership booth, enrolled new Members and attended the Student and Young Professionals reception. And again, she praised the size, quality and professionalism of the event and the enthusiasm of the exhibitors, attendees and Chapter volunteers who make it a success year after year.

As always, the educational programs covered a wide variety of exciting topics

This year, the Product Show featured its first-ever Silent Auction, the purpose of which was to raise seed money for the Joel Goldenberg Scholarship Fund under development by the Chapter. About 20 companies donated valuable items, which helped to raise almost $1600 for the Fund, a great jumpstart for a worthy cause.

The Product Show is the one event that involves all of the Boston Area Chapter's volunteer committees. Its success is a compliment to those who work so hard to make it happen and a testament to the cohesive, get-it-done attitude that permeates The Chapter's energetic and enthusiastic group of volunteers. At times we want to pinch ourselves: is this really happening in our back yard - are we dreaming? No, its just great people doing a superlative job!

Every year, we hear stories about people who miss the Show because they could not get away from work or heard about the Show too late to register. This year the exhibitor booths sold out in July - the earliest ever - and we had a waiting list of exhibitors hoping for a cancellation. Please remember that the date has already been set for 2011: October 5th at Gillette Stadium. So mark your calendar now! And if you plan to exhibit, reserve your booth with a $250 deposit.

Visit the Product Show website at www.ispeboston.org or contact our management office (781-647-4773 or ispe@camihq.com ) for updates and information or to reserve your exhibit space. 2011 will surely be another great year and we hope we see you there!

 

 

Shire HGT President Dr. Sylvie Gregoire Delivers Keynote to Overflow Crowd

by Brian Hagopian, Mar Cor Purification with photos by Kent Van Vliet Photography

The ISPE Boston Area Chapter Product Show featured Dr. Sylvie Gregoire, President of Shire HGT as this year's keynote speaker. The room was packed with over 270 guests who came to hear about Shire's products and their commitment to expansion in Massachusetts.

The overflow audience paid rapt attention as Dr Gregoire described Shire HGT and its commitment to expansion in Massachusetts

Dr. Gregoire began by introducing the audience to Shire HGT's purpose, which is to enable people with life altering conditions to lead better lives. She continued with a brief review of the products already developed and currently under development by Shire which address rare diseases affecting between 1,000 and 30,000 patients globally. Lastly, she focused on Shire's commitment to expansion in Massachusetts. Shire currently employs about 550 people, primarily in Cambridge, but recently made a major commitment to expansion in Lexington and a doubling of its workforce.

Dr. Gregoire touched on several critical factors that led Shire to adopt a "disposables" approach in their new production plant, including flexibility, time to market, automation, and validation. At the conclusion of Dr. Gregoire's talk, Shire's panel of experts were introduced (Paul Slaman, Dave Forney, Jerry Justin, and Bill Ciambrone) and a lively question and answer period followed covering a wide range of relevant topics including disposables, leachables, production flexibility, and much more.

The ISPE Boston Area Chapter would like to thank Dr. Gregoire, the expert panel, and Shire HGT for their participation at the 2010 Product Show.

GAMP Forum Provides a Stimulating Intro to the Annual Product Show

by Deepen Joshi, Sunovion Pharmaceuticals

For the third year in a row, the Product Show was preceded by a half-day GAMP Forum, also held at Gillette. The ISPE Good Automated Manufacturing Practice (GAMP) Community of Practice (COP) sponsors these forums regionally around the world to present current hot topics and facilitate question and answer sessions. They are designed for biopharm professionals from a variety of disciplines who must work together to achieve reliable operation of critical computer systems while meeting regulatory requirements.

Early arrivals got comfortable over coffee and chatted with their peers while waiting for the first session to begin. Since one of the aims is to facilitate networking among peers, the forum was already well on its way toward meeting its goals! The first hour featured Stephen Reich and Kristin Murray, both from Pfizer, who presented "Quality Risk Management (QRM) Tool Selection: Getting to Right First Time." Theresa McCarthy, past chair, American Society of Quality Boston Section, followed with a presentation entitled "ISO 9001:2008 and 21 CFR 210, 211: Working Together for Quality." This topic included something for everyone, as she explained the similarities and differences between ISO and 210/211. She also touched on the legal implications of complying with these requirements.

During the lunch break, topics of conversation included the afternoon Product Show and the upcoming stadium tours, as well the information covered during the morning's presentations. A comment from one of the younger attendees provided a great endorsement for the value of the sessions: "It was a refreshing change to hear two different topics that covered the industry from multiple angles in less than two hours. I can't wait to hear the presentation on FDA's Part 11 initiatives. This is definitely better than a routine day and well worth the price." You can't get a more positive message than that!

Following lunch, Randy Perez of Novartis presented the "The FDA Part 11 Inspection Initiative" as a wrap-up topic. He gave examples of companies that were penalized for not complying with Part 11 requirements. He shed some light on FDA's plan for performing Part 11 inspections and suggested that there might be "some delay" in implementation. He also provided valuable tips on ways to prepare for an FDA Part 11 inspection.

Several of the attendees lingered after the Forum to spend time chatting and exchanging notes with their peers, while others headed to the Product Show. In general, attendees found the information presented both timely and useful. And the combination of the GAMP Forum and Product Show, both held together at the same time and place, provided a double benefit.

Young Professionals Overcome the “Fear Factor” at Product Show

Young professionals gather with Dr Sylvie Gregoire following the keynote address

Four years ago, I attended my first ISPE Boston Area Chapter Product Show. I had been in the industry for just over two years and, I have to admit, the show was pretty intimidating. Of the more than 1000 people in attendance, I probably knew about ten of them. And it seemed like everyone else somehow knew each other. All of the vendors, activity and people were pretty overwhelming. Four years, one job change, a couple of Chapter ski trips and a year of being on the Young Professionals Committee later - and the sheer size of the product show still amazes me. Now, though, I'm more concerned with finding the elusive platter of cocktail shrimp than someone I know to talk to!

 

For the first time this year, young professionals joined student members at an evening reception

The Product Show has grown by leaps and bounds since I first attended. If my first Show was intimidating, I can only imagine how first-timers feel now. This is why the Young Professionals Committee has made an effort to have more of a visible presence at the Show. We have helped put on educational seminars the past two years and this year were able to include young professionals in what was, in the past, an evening reception for student members.

And hopefully, all of the young professional attendees from this year will be able to come to the Show next year ready to re-connect with other young professionals they have met through our events, both at the Show and at the other social and educational events the Young Professionals Committee has sponsored throughout the year.

 

 

 

 

 

 

 

Oktoberfest - A New Tradition is Born!

by Janet Tice, GMP Piping, with photos by Chris Opolski, Alexion

The Chapter packed Tommy Doyle's for our first-ever Oktoberfest celebration

In what is sure to become a new tradition, over 125 Members and guests turned out for the Boston Area Chapter's first-ever Oktoberfest celebration on October 27th at Tommy Doyle's in Kendall Square. Was it the opportunity to network with Members that drew the record crowd? Was it the "best costume" contest? Or the chance to enjoy the Schwarze Schafe Oompah Band, choose from the variety of beers on tap and fill up on delicious munchies (all while wearing bright green Tyrolean hats)? Whatever the attraction, Project Place was the winner, with over $1600 raised for this worthy non-profit offering hope and opportunity to homeless individuals in our local communities.

 

Chapter President Jim Grunwald (l) greeted Members & guests (l to r) Sherwood Butler, Kim Young & Scott Davis

Many thanks to all those who helped make this event a huge success:

• Ultrafiltronics, Alfieri Proctor Associates, Wise Construction, GxP Automation, RW Sullivan Engineering, Triumvirate Environmental and The Boston Bruins Foundation - who generously donated raffle items;
• Signer Harris Architects, P&IDC Construction Professionals, RW Sullivan Engineering, Team SullyMac, Fort Point Project Management and Commissioning Agents - who sponsored the oompah band;
• all who dressed up to vie for the "best costume" award donated by Superior Controls (and congrats to winner...drum roll, please...Joyce Chiu);
• the many Members and guests whose generosity helped us to exceed our fund-raising goal by leaps and bounds;
• and the Social Committee whose energetic and enthusiastic volunteers have created yet another Chapter tradition!

See you next year!

A new Chapter tradition is born, thanks to Oktoberfest committee members (l to r) Carly Starr, Chris Opolski, Michelle Greaney & Paul Sullivan

Young Professionals Combine Fun, Networking and Education

by Jillian Willard, Genzyme, with contributions by Jordan Croteau, Integrated Process Technologies and Josh Strauss, Commissioning Agents, and photos by Aarash Navabi, Genzyme

The Young Professionals had a busy September and October. Not only did the YP Committee begin meeting again to discuss the upcoming year, but we sponsored our first two events of the season. First, we tested our sea legs with a voyage on the Boston Belle around Boston Harbor. Major topics of discussion were our hope for the Patriots after a disappointing baseball season and, of course, networking with the other young professionals lucky enough to catch the boat, all of whom were happy to share their experiences. Since the attendees represented a wide variety of fields and were at different stages in their careers, this proved especially interesting. Everyone had a great time with plentiful food and drink as Captain Mike of the Boston Belle entertained the crowd with seaman's stories.

Young professionals tested their sea legs in September with a voyage around Boston Harbor.

A week later, the Chapter's Young Professionals and Seasoned Veterans met on the beautiful Ebersol fields along the bank of the Charles River in an epic softball showdown. The game began with a live performance of the national anthem by Kim Young of P&IDC. Although the Seasoned Veterans took an early lead, the youthful energy and endurance of the Young Professionals led them to final victory. Afterward, the two teams took a short walk down the street to make peace over food and drink.

Young Professionals and Seasoned Veterans prove they're still friends following an epic softball showdown on the beautiful Ebersol Fields in Boston

The Committee has also been working on a couple of other upcoming events. The first YP educational event will be held on November 17th at Genzyme Center in Kendall Square. Topics covered will be Protein Purification using Chromatography and Project Management. In addition, the YP's will hold their first social event on dry land on December 7th at Flat Top Johnny's, also in Kendall Square. The event will include free pool and appetizers provided by the YP Committee. If you would like to come network with other young professionals or can't wait to hear more of Captain Mike's tales, watch for announcements of upcoming events (including next year's boat cruise and softball games) from the Boston Area Young Professionals.

by Jillian Willard, Genzyme Corporation with photos by Kent Van Vliet Photography

Boston Area Chapter Scores with 8th Annual Golf Outing

by Christopher Opolski, Alexion Pharmaceuticals

Overlooking the course at Ferncroft Country Club

On August 16th, the Boston Area Chapter hosted our annual golf tournament at the Ferncroft Country Club in Middleton, MA. This is the third year that Ferncroft was the site of our event and once again they did a wonderful job. A full field of 36 teams competed on this beautifully maintained course. A few sprinkles in the morning cleared to a mostly cloudy, dry day with low humidity and moderate temperatures; quite a departure from last year's tournament which had seen 95„aF temperatures, high humidity and a cloudless day. The day wasn't just about the golf! Some of the special "extras" of the day included a Dewar's tasting hole and cigars to help golfers on the hole-in-one contest hole.

At the end of play, everyone enjoyed a cocktail reception in the club house. During the reception, 27 contestants that previously sunk a 10' putt during play had a chance to win $10,000 if they first sunk a 30' putt and then a final 50-footer. Unfortunately, a valiant effort by Jason Becker just missed falling in the hole. Congratulations to all of the day's winners.

First place winners, sponsored by Robert W. Sullivan, (l to r) Brian Hagopian, Matt Chardovoyne, Tony Preteroti & Paul Sullivan

Second place winners, sponsored by Erland Construction, (l to r) Bob Liptrot, Bill Piombino, Bob Lewis & Chuck Vaciliou

Third place winners, sponsored by Shilay Associates, (l to r) Tony Schena, Jason Becker, Tom Schiller & Granger Toper

The winning teams:

First Place (61)	Second Place (62)	Third Place (63)
Robert W. Sullivan	Erland Construction	Shilay Associates
Paul Sullivan	Bob Lewis	Granger Toper
Matt Chardovoyne	Bill Piombino	Tom Schiller
Tony Preteroti	Chuck Vaciliou	Jason Becker
Brian Hagopian	Bob Liptrot	Tony Schena

And the individual winners:

	Men	Women
Longest Drive	Justin Edwards	Pat Nugent
Closest to Pin	Tony Pretoroti (2' 2")	N/A
Straightest Drive	Jarrod Dore	Sylvia Beaulieu

Many, many thanks to our Golf Outing sponsors: Decco, Robert W. Sullivan, Cotter Brothers, Structure Tone, DPS Bio, GxP Automation, New England Controls, Superior Controls, Interstate Electrical Services, North Shore Mechanical Contractors, The Richmond Group, Erland Construction, SciTech Builders, TRG Builders, Arion Water, Aztec Technologies, Shilay Associates, Water Consulting Specialists, AES Clean Technology, ValSource, and RDK Engineers, all of whom helped to make this event another big success for the Chapter.

A special thanks to tournament co-chair Michelle Greaney, P&IDC, whose tireless and enthusiastic support helped make this event a huge success. Additionally, thanks to Daniel Rufo, Christopher Hoell, John Ramirez, and Brian Hagopian for volunteering their support during the event.

Millipore Tour Demonstrates Successful Sustainability Efforts

by James Koloski, RDK Engineers, with photos by Joyce Chiu, Perceptive Informatics

On Thursday, June 24th close to 100 people braved a late afternoon thunderstorm to attend a powerful program on the sustainability efforts undertaken by the Millipore Corporation. Following a lively networking reception and light refreshments, David Newman, Millipore's Senior Director for Global Sustainability, reviewed the company's vision and mission to create a more sustainable company while Paul Lukitsch, Millipore's World-Wide Energy Manager, spent close to an hour delivering an in-depth view of the tangible changes Millipore has enacted to meet the sustainability challenge. And the results he described were no less than stunning.

Millipore Corporation treated the Chapter to an upclose and personal look at their sustainability efforts.

Since implementing the program in 2006, Millipore has achieved an impressive 15 percent reduction in greenhouse gasses, a 15 percent reduction in electricity use, a 30 percent reduction in the use of gas for their boilers and cut 22 percent of their water usage, all in demanding manufacturing environments.

Paul reviewed several projects that Millipore has undertaken to achieve these goals including a building envelope project that took the insulation value of a building housing a newly constructed clean room from an R1 to an R22. He also reviewed the construction of a new clean room that gets all of its electricity from Green-e certified wind energy. This exceeds the LEED requirements by a full 35 percent.

Paul Lukitsch, Millipore's World-Wide Energy Manager, described the many changes undertaken by Millipore to reduce energy use.

Following the presentation, attendees divided up into smaller tour-sized groups and were led on an interactive tour of the Bedford facility. A unique "shotgun-start" approach allowed each of the groups to ask tons of questions of the Millipore staff people manning each stop. Attendees were able to view the extensive solar arrays and inverter room that provide a portion of the facility's electricity. They got an up-close view of an individual solar panel demonstration in the courtyard that powered one of Millipore's Milli-Q Integral systems.

Individual motion-controlled, energy efficient T-5 fluorescent lighting in the warehouse illuminated another stop on the tour. Not only did the new lighting save electricity, the brighter illumination significantly reduced warehouse "pick errors," an additional and totally unexpected money saver. Yet another stop described a project that analyzed the use of compressed air, then achieved a significant KWH savings by using enhanced leak detection and lowering the overall operating pressure from 110 to 90 psi.

Light was also shed on a project in the cafeteria where the meeting took place. Millipore had retrofitted the lighting fixtures with digital dimming ballasts, occupancy sensors and wall controls to create a "light harvesting" environment that reacts to the room's usage and daylight availability to obtain maximum efficiency. At another stop, this time in the boiler room, everyone was able to view the controls enhancements to the existing boilers. that realized a 29 percent reduction in gas consumed and a 0.9 year simple payback.

Given all of this, probably the most talked about stop on the tour was to review the implementation of over 1,100 plug load controllers in individual employee workstations. The controllers provide a mix of continuous power and motion detected outlets that shut down non-critical equipment in each workstation when it is vacant. Everyone on the tour immediately saw a need in their own teenager's bedrooms for these controllers.

Many thanks to Dave Newman, Paul Lukitsch and their staff at Millipore. They provided extensive help in putting this program together and making it such a huge success. If you're interested in finding out more about the company's commitment to sustainability I would encourage you to visit the sustainability section on the company's website at www.millipore.com.

ImprovBoston Creates a Splash at the Summer Social

by Janet Tice, GMP Piping, with photos by Joyce Chiu, Perceptive Informatics

Outgoing President Sylvia Beaulieu thanked volunteers for their contributions to the Chapter.

In another "first" for the Boston Area Chapter, members and guests gathered at the Hard Rock Café in downtown Boston on June 16th for an evening of food, drink, networking and a live performance by the ImprovBoston comedy team. The Chapter used the event to honor our many hardworking volunteers, all of whom were invited to attend at no charge. In addition, they received a special thank you from outgoing President Sylvia Beaulieu for their invaluable contributions to the Chapter during the past year and a voucher for free attendance at an educational program of their choice during the upcoming 2010-11 program season. (Those volunteers who missed the event will receive their voucher in the mail.)

Incoming President Jim Grunwald fornd himself in the hot seat during ImprovBoston.

As if that weren't enough, the event also acted as a benefit for Backpacks for Kids, a local nonprofit that donates backpacks complete with school supplies to Boston area children in need. Attendees who brought back packs and/or school supplies received free tickets for raffle items generously donated by RW Sullivan (Red Sox tickets), Integrated Builders (video camera), Hard Rock Café/ImprovBoston ($150 gift certificate), American Plant Maintenance (autographed Celtics photo) and GMP Piping (Red Tail Golf Club, Devens - $200 gift certificate plus private golf lesson).

 

Boston's Hard Rock Cafe provided an exciting backdrop for this year's Spring Social & Volunteer Appreciation.

All in all, attendees donated 10 backpacks, two Red Sox gym bags and tons of school supplies. Plus, the event raised over $300 for the purchase of additional supplies by Backpacks for Kids which is now well on its way toward reaching its goal of 500 backpacks this year, thanks to generous ISPE members!

Another brave Chapter Member takes the stage...

After an hour or so of socializing and snacking on a dazzling array of appetizers, members were coaxed into their chairs for ImprovBoston whose members provided entertainment custom-crafted especially for the Chapter. Comedy routines were created on the spot - that's why they call it improv! - with the life sciences industry and those who work there as the central theme. Chapter Officers Sylvia Beaulieu and Jim Grunwald took more than their share of ribbing - proving they each have a sense of humor equal to their leadership skills. Jim even took the stage at one point for a prolonged (and hilarious) interrogation by the Improv team. To his credit, he kept his cool throughout - good practice for the role of Chapter President!

Many thanks to Chris Opolski and his hardworking Social Committee who did a great job creating another fun and relaxing get together for Chapter members. And special thanks to all the volunteers who dedicate their time and effort to making the Chapter shine!

Members Explore Career Options with Industry Leaders at Tufts Gordon Institute

by the Membership Services Committee with photos by Joyce Chiu, Perceptive Informatics

On a warm Thursday evening on June 10th, local professionals met at Tufts Gordon Institute in Medford to see old friends, make new ones and, more importantly, learn from a panel of nine experienced industry leaders, all from different fields and companies. This unique event was organized by the Boston Area Chapter Member Services Committee to assist individuals looking for information to help them grow professionally or those interested in exploring a variety of different career options in a single evening.

Tufts Gordon Institute host Mary Viola enjoys a light moment with attendees.

After a "welcome" reception (with a great array of dinner items), Gordon Institute Professor Mary Viola formally welcomed the panelists and attendees to Tufts. Her comment that one of the Gordon Institute's goals is "Helping Engineers and Scientists" struck a great opening note. Next, the nine panelists introduced themselves and opened with brief remarks in three areas: what inspires them about their jobs, how they had overcome a hurdle in their careers and one piece of advice on how to succeed in their field.

Although each of the panelists was from a different discipline, a few common themes were evident:

• be willing to try something different, something out of your comfort zone;
• recognize the virtue of having patience; and
• keep an open mind regarding new possibilities in one's career track.

Panelist Cheryl Marrotta of Genzyme with Barry Potts (left) and Ric Feldt of the Chapter's Member Services Committee.

After the welcome and panelists' introductory comments, five breakout sessions were held with the panelists, with participants able to visit with each for fifteen minutes in a friendly round-table atmosphere. The following are some of the highlights of these discussions:

Beth M. Wescott, P.E. Operational Excellence :
Director, Site Operations Management, Andover, Pfizer Global Manufacturing

Beth discussed issues such as how to facilitate, how to consolidate resources, the importance of "learning the ropes" in an organization and how to get people better involved in continuous improvement.

Cheryl Marotta Corporate Quality :
Vice President, US Therapeutics Quality Operations, Genzyme

Cheryl hosted a lively session that spoke to points such as how important it is to find the time to make improvements, to get out of a reactive mode and become more proactive. She recommended getting out of one's comfort zone (a point echoed by several of the panelists) and described her career ladder of different companies (Millipore, Ion Pure Technologies, Genzyme) and various quality positions. She also spoke of the advantages of being able to connect to people on an individual level, person to person, rather than through formal positions.

Michael J. Kaufman, Ph.D. Pharmaceutical Product Development :
Vice President, Pharmaceutical Sciences, Millennium: The Takeda Oncology Company

Mike spoke of the day-to-day management required for his position and how this related to bringing new pharmaceuticals to market. He also answered questions regarding how he learned to plan and budget for large scale projects.

Susan Dana Jones, Ph.D. Biotech Process Development & Tech Transfer :
Vice President and Senior Consultant, BioProcess Technology Consultants

Susan described what her job entails on a day-to-day basis and how she started her own company, helping to shape the future with her past experience.

Bob Steininger Biopharmaceutical Manufacturing:
Senior Vice President, Manufacturing, Acceleron Pharma

Bob discussed his experiences at small and larger companies and the levels of expertise that can be acquired at both sizes of companies. He also gave advice to those wanting to switch from lab/office management into managing drug development projects.

Robert Mitchell, P.E. Architecture & Engineering:
Vice President, Engineering, SPEC Process Engineering & Construction

Rob stressed the importance of learning the history of the field you're in and described his career experiences and how they shaped his approach. He also spoke of sustainability (green engineering) and stressed that this new directive can be addressed by employing good engineering practices, that is, by doing the right thing.

Lisa Wyman Production Engineering:
Senior Production & Engineering Manager, Boston Scientific

Lisa discussed topics such as lean engineering, as well as how important it is to prove the connections between quality, customers and costs. Some key points of her advice included create opportunities to keep learning, take on responsibility and find mentors.

Roop Kumar Automation Engineering:
President & Founder, Aztec Technologies

Roop discussed some technical aspects of what his company provides and how he overcomes some common hurdles, as well as how the experiences from his past positions at such companies as Wyeth and Amgen have shaped the approaches he used at his own company.

Peter Mosgrove Business Development, Sales & Marketing:
Head of Marketing, Mettler-Toledo Thornton

Peter discussed how important it can be to take different avenues in one's career and how important those experiences were in his own career. After being a part of R&D, then sales, he enjoyed marketing because it allowed him to help educate people on what products can do.

Panelist Lisa Wyman of Boston Scientific with attendees (l to r) Bernadette St. John, Nancy Buczko and Cynthia Laksawana.

Attendees at this unique event - from young professionals to seasoned veterans - were offered a rare opportunity to gain personal insights from a diverse group of distinguished industry professionals, all in a single evening. One of the attendees in particular, an enthusiastic high school student, seemed especially pleased with the information she gained. We hope this event helps her formulate her future career direction.

Acceleron Facility Tour and Single-Use Technology Draw Overflow Crowd to Cambridge

by Keyur Doshi with photos by Viriya Shloul, both of Acceleron Pharma

They came, they saw, they learned! There is no better way to describe the level of enthusiasm exhibited by the sheer number of people who took part in the Single-Use Technology Seminar and Facility Tour at Acceleron Pharma in Cambridge on May 11th.

Chapter Member and Meeting Manager Keyur Doshi (r) of Acceleron led one of the groups that toured the Acceleron facility.

The evening began with a Members-only tour of the Acceleron Pharma Clinical Manufacturing Facility. This was a unique opportunity for Chapter Members to view first-hand some of the interesting approaches taken by Acceleron in its early phase, clinical GMP facility.

Following the tour, the evening's first speaker - Acceleron Senior VP of Manufacturing Bob Steininger - provided great insight into the company's pilot and GMP manufacturing strategy and how the concept of a disposable facility complements that strategy. He described the design basis of the disposable aspect of the facility which incorporates some interesting concepts like no purified water or steam system...something unheard of only a few short years ago.

A standing room only crowd listened attentively as a series of speakers discussed various aspects of single-use manufacturing technology.

In the second talk of the evening, speakers Paul Slaman of Shire HGT and industry consultant James Vogel provided an overview of Shire's implementation of single-use systems at their Lexington facility. The core topics they discussed were Shire's single-use business processes which include material selection, process evaluation and material/process comparison. They also emphasized a critical factor in such assessments: a successful owner-vendor partnership.

The third and final talk of the evening by Xcellerex President and CEO Parrish Galliher was extremely informative as he reviewed the current state of industrial research in new technologies for single-use manufacturing, especially downstream processing. Some technologies, such as single-pass ultrafiltration and pre-packed chromatography, looked very promising and have already generated a lot of curiosity. Others, like simulated moving-bed chromatography and expanded-bed chromatography, though still in their nascent stage, have demonstrated significant savings - in case studies at least.

We need to thank everyone who made this event a success, not least of all the many Boston Area Chapter professionals (over 100) who turned out for the event and took part in a lively discussion on single-use systems. Beyond a doubt, this event was a huge success and managed to generate a lot of excitement among Chapter Members, demonstrating the high level of interest in this area of technology.

25 Chapter Members Take the Challenge, Join CPIP™ Study Group

by Janet Tice, GMP Piping, with photos by Joyce Chiu, Perceptive Informatics  

CPIP Study Group leadership is ably provided by Chapter Past President Doyle Johnson.

In another first for the Boston Area Chapter and ISPE in North America, the Chapter has successfully launched its CPIP Study Group. With its kickoff meeting on May 26th, the goal of the Study Group is to make it convenient and fun for qualified Chapter Members to obtain the CPIP - Certified Pharmaceutical Industry Professional credential. Available only through ISPE, the CPIP credential establishes a "global competency standard" for industry professionals working in and supporting product development through manufacturing. It is intended to recognize those in the industry whose experience and knowledge make them outstanding leaders. Candidates are assessed through demonstrated education and experience, which involves a rigorous application process and a written examination. 

Following several months of publicity, both formal and word-of-mouth, 25 Chapter Members stepped forward to join the Study Group, recognizing the benefit of group effort, free course materials (generously provided by ISPE), convenient and comfortable classroom space courtesy of Genzyme in Framingham and expert leadership provided by Chapter Past President Doyle Johnson as CPIP Study Group Leader. Candidates are a diverse group, representing the full spectrum of Chapter membership in terms of years in the industry, job function, company type and gender.

 

Study Group members represent the full spectrum of Chapter membership in terms of years in the industry, job function, company type and gender

At the first session, CPIP and Chapter veteran Allan MacDonald shared his personal experience completing the CPIP application and exam, giving candidates a good grasp of what to expect and how to approach this somewhat daunting process. The Study Group has adjourned for the summer, allowing members to independently work on their individual applications, but will resume in the fall with another round of three-hour study sessions (10 in total) in preparation for an October exam. To quote one Study Group member, "There are questions to be answered at the end of each learning objective and the class has a lot of fun with them. If everyone does as well as the class, we'll all pass the exam!"

GAMP Forum Provides a Stimulating Intro to the Annual Product Show

 

by Deepen Joshi, Sunovion Pharmaceuticals

 

For the third year in a row, the Product Show was preceded by a half-day GAMP Forum, also held at Gillette. The ISPE Good Automated Manufacturing Practice (GAMP) Community of Practice (COP) sponsors these forums regionally around the world to present current hot topics and facilitate question and answer sessions. They are designed for biopharm professionals from a variety of disciplines who must work together to achieve reliable operation of critical computer systems while meeting regulatory requirements.

 

Early arrivals got comfortable over coffee and chatted with their peers while waiting for the first session to begin. Since one of the aims is to facilitate networking among peers, the forum was already well on its way toward meeting its goals! The first hour featured Stephen Reich and Kristin Murray, both from Pfizer, who presented "Quality Risk Management (QRM) Tool Selection: Getting to Right First Time." Theresa McCarthy, past chair, American Society of Quality Boston Section, followed with a presentation entitled "ISO 9001:2008 and 21 CFR 210, 211: Working Together for Quality." This topic included something for everyone, as she explained the similarities and differences between ISO and 210/211. She also touched on the legal implications of complying with these requirements.

 

During the lunch break, topics of conversation included the afternoon Product Show and the upcoming stadium tours, as well the information covered during the morning's presentations. A comment from one of the younger attendees provided a great endorsement for the value of the sessions: "It was a refreshing change to hear two different topics that covered the industry from multiple angles in less than two hours. I can't wait to hear the presentation on FDA's Part 11 initiatives. This is definitely better than a routine day and well worth the price." You can't get a more positive message than that!

 

Following lunch, Randy Perez of Novartis presented the "The FDA Part 11 Inspection Initiative" as a wrap-up topic. He gave examples of companies that were penalized for not complying with Part 11 requirements. He shed some light on FDA's plan for performing Part 11 inspections and suggested that there might be "some delay" in implementation. He also provided valuable tips on ways to prepare for an FDA Part 11 inspection.

 

Several of the attendees lingered after the Forum to spend time chatting and exchanging notes with their peers, while others headed to the Product Show. In general, attendees found the information presented both timely and useful. And the combination of the GAMP Forum and Product Show, both held together at the same time and place, provided a double benefit.

 

18th Annual Product Show Attracts Record Turnout

by Mark Sitcoske, High Purity New England, Inc. with photos by Peter Teague, Boston Scientific, Inc.

The "Perfect Storm?" Maybe not quite but, with all indicators working against us, the ISPE Boston Area Chapter pulled off another outstanding success and once again enjoyed a record turnout for the 18th Annual Product Show at Gillette Stadium. Our industry has not been immune to the economic downturn that has hit the country and the rest of the world but the Boston Area Chapter, its wonderful volunteers, great Chapter management, supportive Board and great vendor community pulled off the unexpected. We sold out the Show two months earlier than last year, had record attendance and demonstrated that biopharm is not only alive and well but prospering in this economic climate. 

An expansive view of Gillette stadium always provides an exciting backdrop for the Show	The day began early with the half-day GAMP Forum

From Keynote Speaker Juan Enriquez to the outstanding educational program, the Boston Area Chapter is truly leading the way. With 278 vendors displaying their wares and over 1800 attendees buying, networking and learning, industry know-how was hard at work.
Not only is this a compliment to all who worked so hard to make this event a smashing good time, it is also a testament to our cohesive, get-it-done Chapter. At times we want to pinch ourselves and ask, "Is this really happening in our back yard or am I dreaming?" No, its just darn good people doing a darn good job!  

Over 275 vendor booths were a magnet for attendees

 I've heard it said that the long shadow of Gillette Stadium reaches all the way to Fenway. While the Boston Area Chapter of ISPE may not have quite that long a shadow, it has a loyal and enthusiastic following within the New England biotech community similar to the strength of the Boston area teams - and 2009 was no exception. The outstanding array of educational offerings that included a world class keynote speaker, nine education seminars and a half-day GAMP Forum - not to mention the products and services on display from the full spectrum of vendors that serve the industry - attracted attendees from all over New England. 

Multiple food stations ensured that visitors were kept well-fed throughout the day	The introductory level educational sessions incuded an update on ASME BPE Guidelines

And the many amenities offered at the Show sealed the deal. Some might say the Boston Area Chapter travels on its stomach and those who attended the Product Show would certainly agree. The food is always outstanding in both quantity and quality and 2009 was no exception. Comfortable seating areas for relaxed conversation completed the picture, all with an unparalleled view of the stadium. Who could ask for more? (Product Show parking and admission are always free, of course. (Oh, and did I mention the food is free too?)

Every year, everyone on the Product Show Committee reports someone who missed it, someone who could not get away from what? or a vendor who registered too late to secure a booth. This year, the exhibitor booths sold out in August, the earliest ever. The date is already set for next year: October 6, 2010 will be another great day at Gillette. Be sure to plan ahead so you'll be there to share the excitement. 

A Special Thank You to Peter Teague The ISPE Boston Area Chapter relies on the efforts of so many volunteers. From running programs to writing newsletter articles to organizing recreational events, there are few functions that are not supported by the work of these volunteers. As many people noticed during the recent Product Show, photos were being taken. For several years we have relied on eminently capable Chapter volunteer Peter Teague for this critical contribution. Peter's photos are always memorable, interesting and many times "over the top." We would like to take this opportunity to recognize Peter for applying his professional level skills on our behalf with such great enthusiasm and creativity. Thank you, Peter, for a job exceptionally well done!

Product Show Breaks New Ground - AGAIN!

by Brian Hagopian with photos by Peter Teague and Gail Fischer

In the words of one attendee, "You'd be crazy to miss this show.  It has everything!" We couldn't have said it better ourselves...

The Boston Area Chapter recently held its flagship event, the 17 ^th Annual Product Show, at Gillette Stadium.  Attendance at the show reached record highs this year, thanks to the efforts of a large group of volunteers from the Chapter. 

Past President Rick Pierro, current President Doyle Johnson and audience show how much fun it can be to be a part of ISPE!

A few "firsts" at this year's show included:

    *   ISPE and GAMP synergized in a first ever, day long session

   *   ISPE International attended the show

   *   Patriot Hall of Famer John Hannah was a keynote speaker

   *   CNN (that's right, THE CNN we all watch on TV) visited the show and shot footage

The day long event started earlier than ever before, with the Educational Committee adding two three-hour morning sessions, one covering fluid mixing and one covering GAMP.  One informative session was presented by Chemineer which detailed fluid mixer design, application, and use.  The GAMP® 5  session was presented by a team of instructors from Wyeth, Genzyme, and Novartis with high attendance.  The Chapter also sponsored six afternoon sessions rich in content and covering pumps, automation, leadership, GAMP® 5, project management and chromatography.  The subject matter was such that ISPE Members traveled from as far as California to attend these technical sessions.

The Boston Area Chapter broke new ground this year in working with the GAMP team to sponsor their presentations and breakout sessions throughout the day.  Participants were able to attend these sessions for FREE.  The success of this session was brought to the fore at the ISPE Annual Meeting in the hope that the winning formula in Boston can be replicated by other Chapters throughout the country. 

 

New England Patriots Hall of Famer John Hannah entertains the crowd with great stories!	Students from UMass Amherst pore over employment opportunities at the Career Center.

Lynne Richards from ISPE's international headquarters in Tampa made the trip to Gillette as the Boston Area Product Show has received much national recognition in recent years.  She staffed the ISPE membership booth and had the opportunity to take in all the Show had to offer.  The Chapter added a record number of new members to ISPE during the Product Show thanks to Lynne's work and that of several local Board Members.

The Product Show held its second career fair this year with hiring companies Biogen, Shire, Bristol-Myers Squibb, Vertex, Astra Zeneca and others in attendance.  CNN, which was researching a story for companies hiring in these trying economic times, learned of our career fair and visited the show to interview hiring companies, as well as candidates.

Amenities such as carving stations and hot and cold hors d'oeuvres were available throughout the day.

Product Show Committee Chair Brian Hagopian with CNN's Dan Lothian.

Last but not least, the Show featured two keynote speakers, one to open the show and a second in the late afternoon.  Dr. Joey Norikane from Fraunhofer CMB spoke on the topic of producing vaccines using plant-based vehicles.  New England Patriot and NFL Hall of Famer John Hannah, the most decorated Patriot of all time, regaled attendees with great stories from his life as a Patriot and had the audience in stitches.  We learned that John is much more than just a retired football player.  He continues his involvement with the Patriots and regularly attends home games at Gillette, where he hosts "Hannah's Huddle."

Throughout the day, people I encountered described the reasons why they attended the show.  From exhibitors:

  *   Our company exhibits at every local ISPE show and Boston's is by far the best local show in the country.

  *   Our company did a million dollars worth of business at the show.

From attendees:

  *   Everyone serving our industry is under one roof.  I've never seen anything like this on a local level.

  *   I flew in from the west coast to attend the educational sessions.

  *   You'd be crazy to miss this show.  It has everything.

  *   GAMP sessions for free, that's amazing!

About $2,000 in gift certificates and Patriots' memorabilia were raffled off throughout the day.  Shawn Callahan from FW Webb was the lucky recipient of a Patriot jersey autographed by John Hannah.

It was great to see the entire Boston Area Chapter Board of Directors at the Show as well as many Members from the Chapter's Advisory Board.  If you are looking to meet with the brain trust of the Boston Area Chapter, the Product Show is the best place to do so.

Keynote Speaker Dr. Joey Norikane with Past President Dave Novak.

 

The Product Show committee strives to make each show new and exciting.  Whether you attended or exhibited, you should have received a survey, which we encourage you to complete.  This is our major vehicle for feedback and we want yours!  If you have any suggestions, comments or input, either positive or negative, we would like to hear from you.  If you prefer a different method of providing feedback, feel free to contact any member of the Product Show Committee or email us at ispe@camihq.com .

The Product Show Committee already has a few surprises planned for next year's show, so stay tuned for updates.  The date has already been set - October 7, 2009 - so please mark your calendars and save the date.  You can visit the Product Show website year round at http://www.ispeboston.org/ for updates and information.

 

 

 

  Annual Product Show Does it Again!

by Brian Hagopian with photos by Peter J.B. Teague

An aerial view of Gillette Stadium provides a spectacular backdrop for the Annual Product Show.

When you think it is impossible to improve upon last year's product show, this year's show exceeded even the committee's expectations. Clearly, word got out about last year's show, making this year's show even bigger and better. Gillette Stadium, home of the three-time (soon to be four-time) world champion New England Patriots provided an exciting and spacious backdrop once again (and we've signed a contract to host the show at Gillette for the next two years.). The combination of two excellent keynote speakers, unlimited parking, six well-attended educational programs, over 260 exhibitors, a career fair, and great food produced a show that surpassed last year's show! And this year, the Product Show website (www.ispeboston.org) was in full swing, making it easy for both exhibitors and attendees to register for the show.

Here are a few statistics about this year's show. Attendance was up by 15 percent over last year - to a best-ever 1,600 registered guests - and up by over 75 percent since the show moved to Gillette two years ago. The show offered afternoon and evening keynote speakers, over 260 exhibitors displaying their latest products and technologies, a continuous series of educational seminars (see related article) and an expanded career fair, with HR representatives from 15 companies on hand to chat with attendees (see related article).

Stadium tours offer an opportunity to step onto the artificial turf at field level.

Each attendee received a complimentary raffle ticket at registration. Prizes were given away throughout the day, with lucky winners sharing over $1,500 worth of gift certificates. In addition, several exhibitors raffled off tickets, Patriots' gear, and other valuable items during the show. Stadium tours were available for a limited number of lucky people who were able to see one of Gillette's luxury boxes, the visitor's locker room, and step onto the artificial turf at field level.

Regardless of whether you exhibited or attended, this show really has become a "can't miss" event. If you m ade the time to attend, you know what we're talking about. If you missed it, you missed something really superb. Gillette was a buzz of activity all day long, kicking off with afternoon Keynote Speaker Deborah Shelton from Sheppard, Mullin, Richter & Hampton LLP. Ms. Shelton gave a great talk to a large crowd on the subject of bio-generics, a topic that is evolving and will be of great interest to the local community for years to come.

Evening Keynote Speaker Dave Petko presents "The End of Validation as We Know It" to a rapt audience.

Our evening Keynote Speaker, Dave Petko from Auxilium, spoke on changes occurring through ASTM in the area of validation. Registration for the six educational programs broke all prior records, with at least 100 people pre-registered for each of the talks (see related article).

It was great to see the entire Boston Chapter Board of Directors at the show as well as most members of the Advisory Board. If you are looking to meet with the brain trust of the Boston Area Chapter, this is probably the best place to do so. Not to mention the opportunity to network with 1600 or so of your peers in the industry!

The show floor was a hub of activity throughout the day..

The Chapter took full advantage of Gillette's amenities, holding seminar s upstairs in the luxury box level, arranging for stadium tours, and inviting attendees to relax outdoors in the "red seats" overlooking the field. With the great weather, sitting outside in the stadium was a real treat. The natural light pouring in through three stories high windows created a bright, lively, and vibrant exhibit area and once again, the food at Gillette was sumptuous and plentiful. And while the parking lot immediately in front of the show filled up quickly, free parking remained available for another 50,000 or so cars!

The Product Show Committee should be commended for putting on a great event this year. The show was successful because so many people devoted long hours during the planning stages of the show.

The Product Show guide provides a useful resource for attendees - during the show and throughout the year.

Please go out of your way to thank the following Chapter members for their extraordinary efforts in helping to make this show a success: Tim Crowley from Sentrol, Doyle Johnson from UMass Medical, Mike Denault from Denault Associates, Mike Matton from New England Sales, Mark Sitcoske from High Purity New England, Peter Teague from Boston Scientific and Brian Hagopian from Fluid Solutions/ Mar Cor Purification. Thanks as well to the Educational Program Committee for the great job they did in putting the programs together. And last but not least, special thanks to our past and current Chapter Presidents, whose leadership was unwavering throughout the year. Thanks Mike and Rick!

If you exhibited at or attended the show, you should have received a survey so you can tell us what you liked and how we can improve. If you haven't filled out a survey, please do so! It's the only way we can make the show better for you. If you didn't fill out a survey but have a suggestion for us, would like to learn more about future shows, or want to become part of this or another Chapter committee, please contact us at ispe@camihq.com. Giving your time to the Boston Area Chapter helps the Chapter grow and prosper and is a very rewarding experience.

With the glow of a successful show still in fresh in our memories, it's already time to start planning for next year at Gillette. To keep the show fresh every year, new ideas are already being considered to make this event even better. The success of this year's show makes planning for next year's a lot easier! The Product Show Committee is proud for having organized what many exhibitors have described as the best local ISPE Product Show in the country. It's going to be a real challenge for us to top this show next year but I know we'll succeed! To those who came and participated, thanks and stay tuned.

 

 

 

 

Product Show Educational Program Attracts Record Turnout

text and photos by Peter J.B. Teague

Keynote speaker and Special Counsel Deborah M. Shelton addresses an attentive audience regarding "Biosimilars", aka Biogenerics.

The 16 ^th Annual Product Show held at Gillette Stadium on October 17 ^th was indeed a record setting event for the Boston Area Chapter, with eight successful educational programs drawing over 530 attendees and "fans" of ISPE. Kick-off took place at 1pm with Keynote Speaker Deborah M. Shelton , Special Counsel with Sheppard, Mullin, Richter & Hampton LLP, who flew in from Washington, DC. Ms. Shelton concentrates her practice in FDA law, with a particular emphasis on regulatory issues relevant to the pharma, biotech, and medical device industries. Nearly 90 attendees listened attentively to her information-packed presentation, The Hot and Heavy Debate: Biosimilars in the US and the Potential Reshaping of the Biotechnology Landscape. Some key points that Deborah covered included the status of federal laws governing biogenerics, abbreviated approval pathways, and the FDA's current opinion on the subject.

Paige Kane of Wyeth Biotech presenting "Back to the Future: GEP, GAMP & You".

The "first quarter" of the program included Greg Rutlic and Paige Kane , both of Wyeth Biotech, who presented Back to the Future: GEP, GAMP, & You, which covered such timely topics as Good Engineering Practice and what's new in the ISPE GAMP 5 guide, as well as some great examples.

George Dainis (Industrial Facilities Design, Inc.) spoke on Capturing the Need: Preparing a User Requirement Specification (URS) . Nearly 50 persons attended George's talk, which included something for everyone, as he explained how a thorough URS document is extremely important to the success of a project for both the vendor and the end user. He also gave examples of detailed requirements for a URS, covering items to include and - just as important - those to avoid.

Jack Greene (Alkermes) presented Using ISA-88 and GAMP to Reduce Plant Startup Timelines . This was a great talk on S-88, as Jack included everything from definitions and traditional C&Q (Commissioning & Qualification) approaches for beginners, to advanced ASTM E-55 C&Q hybrid models and lessons learned from his years of experience with the subject.

Peter Petrillo discusses a state-of-the-art process for monitoring water systems for the presence of rouge .

Next, three experts teamed-up for a state-of-the-art presentation on monitoring water systems for the presence of rouge and creating a novel predictive maintenance program. Peter Petrillo (Millennium Facilities Resources, Inc.), James Dean Vogel, P.E. (Process Facilities Services, Inc.) and Jeffrey Pouliot (Amgen) presented an extremely interesting talk, while a record 100 attendees followed closely along. Is Rouge Really a Problem? A Science-Based Approach to Clean Steam and WFI System Maintenance started with background information on rouge and passivation. This introduction, combined with analytical test methods, and a great case study with new data, proved to be a "big hit" with the audience.

David Petko describes the new ASTM E2500 standard that could change validation as we know it.

A 5pm "halftime" keynote speaker was planned this year and was successful in helping to draw additional attendees during the second half of the show. David Petko (Auxilium Pharmaceuticals, Inc.) was actually brought back by popular demand, as a result of attendee feedback from online ISPE surveys. David's presentation on The End of Validation as We Know It: A Science and Risk Based Approach to Commissioning and Qualification at the joint ISPE Boston Area/New England Chapter session in June was so successful that he gladly returned for an encore presentation. The ASTM E55.03 working group (which David co-chairs) was responsible for releasing the new ASTM E2500 standard on specifying, designing and verifying pharmaceutical manufacturing systems and equipment. David's talk included up-to-date information on the new standard and he was later joined by speaker Graham Wrigley, PhD , who walked through a case study on the subject from Pfizer, where he is a Senior Manager.

Chuck Crumpton (Medpoint, LLC) flew in from Greenville, SC for a super "fourth quarter wrap-up," ending a great day (and night!) of presentations by teaching attendees to Make Your Career Rock! It was certainly a great title for a great talk. Although it was scheduled later into the evening and thus fewer persons were in attendance, the audience didn't want to leave when the presentation concluded! Chuck stayed well past his scheduled time just to answer questions and to meet one-on-one with many persons seeking to advance their careers. Rumor had it that he was giving autographs too!

Attentive audiences and "sold-ou" presentations were the rule for the educational program.

Overall, the sessions were very educational and certainly timely for the industry. The speakers were presented with ISPE-personalized gifts and received great ratings in the "fifth quarter report" (i.e. the after-show survey) as well. Several of them commented that this was the most fun show they have presented at and the audiences were great! This win was only possible, however, through a team effort from ISPE Education Program Committee (EPC) members, who worked extremely hard to make our "game day" a success! Many thanks to our entire team!

 

If you would like to join the EPC and help out with our upcoming monthly programs, as well as Product Show 2008, please contact Chapter Manager, Amy Poole at 781-647-ISPE or ispe@camihq.com . I hope to see you soon at one of our upcoming ISPE Boston Area Chapter Educational Programs and also next year at an even BIGGER and better Product Show 2008!

Boston Area Chapter President Rick Pierro with Keynote Speakers Deborah Shelton and David Petko.

 

Career Fair Strikes Gold at Product Show

This year's Product Show boasted the Chapter's first dedicated effort to host an active career fair during the Show. At prior Shows, areas were made available for companies to post open positions and for candidates to drop off resumes. Last year, two companies brought their HR folks. This year we wanted to expand on the concept, so we sought out the human resources departments of major companies in the area and asked them to bring their HR people to this year's "Career Connection." The result was a resounding success, with 13 companies helping to make this year's career fair a great one.

HR representatives from area companies chatted with attendees throughout the day at the Career Connection.

Gillette Stadium has plenty of space, so a semi-private area was created for the companies to convey their message. Just walking through the area, the Career Connection had an energy about it and was bustling with activity throughout the day. The Product Show provided an excellent opportunity for each company to meet a large number of qualified candidates and discuss open positions and career advancement. Our thanks to the HR departments at Alkermes, Shire, Wyeth, Bristol-Myers Squibb, AstraZeneca, Biogen Idec, Abbott, Lonza, Genzyme, Vertex, PMA Consultants, Acceleron Pharma, and New England Controls for participating.

After speaking with the participating companies following the Show, the overwhelming consensus was that the Product Show represented both a great venue and a great value for their companies and they would definitely be back next year. Since word will surely spread about this year's success, the Product Show committee is already planning to allocate additional space for more companies next year. To those who participated this year - again, thanks. To participate next year, contact the Chapter office at ispe@camihq.com

MIT Professional Institute Co-Sponsors “Bridging the Gap between Laboratory Research and Industrial Applications”

by Paul L. Smock, ISPE Boston Area Chapter Past President, with photos by Chris Opolski, Alexion Pharmaceuticals

On Tuesday, April 8, the Boston Area Chapter presented an educational program at the Cambridge Hyatt Regency. The venue was the Charles River room, high atop the hotel with a spectacular view of the Charles River and the Boston skyline. We were also treated to some really excellent hors d'oeuvres while networking prior to an outstanding program that began with Joyce Chiu of the Membership Services Committee outlining the benefits of ISPE membership. She was followed by Chapter Past President Doyle Johnson, who introduced the program and speakers.

Our first speaker was Professor Bernhardt L. Trout, Professor of Chemical Engineering at MIT and Director of the Novartis-MIT Center for Continuous Manufacturing and Co-Chair of the Singapore-MIT Alliance Program on Chemical and Pharmaceutical Engineering. His talk was centered on his group's research on modeling protein degradation processes to develop rational approaches to stabilization. Aggregation, oxidation, deamidization and hydrolysis were all presented as degradation pathways, but the bulk of the presentation was focused on aggregation and the application of molecular level quality by design (QbD) to counter this process for antibody stabilization.

Dr. Trout's group has used modeling techniques followed by application of a tool to assess spatial-aggregation-propensity (SAP) to identify both highly hydrophobic and highly hydrophilic regions of the antibody molecule, recognizing that the interactions of these regions is one of the major causes of aggregation. In addition, the SAP tool can predict both protein binding regions, and can be used to rank prospective molecule variants in terms of their potential for development as stable products. Lastly, he presented some experimental data demonstrating how well the actual results fit the predictions, and argued that this approach should be used from early product/process development forward to develop a mechanistic understanding and allow for the rational design of stable products.

Our next speaker was Dr. Anirban Chatterjee, Scientist at Fraunhofer Center for Manufacturing Innovation (CMI). At CMI, teams of engineers and scientists work closely with clients and partners to design, manufacture, test and optimize prototype devices and instruments in the areas of mechanical, biotech/biomedical, photonics, and alternative energy. His talk was focused on some work done in partnership with Boston University on the design and development of medical devices, biomedical instruments and research tools. He highlighted porous polymer monolith, invented by Dr. Catherine Klapperich at BU, and its application in lab-on-a-chip diagnostics and automated sample preparation. In the case of the lab-on-a-chip application, he showed us how that had been integrated into an instrument system comprised of three major systems - fluidics, thermal, and optical - and went on to demonstrate how that instrument had been put into service as a high throughput nucleic acid sample preparation tool. Dr Chatterjee concluded his talk with three other examples of innovative work around automated tissue homogenization, bacteria concentration and purification, and automated myocite cell isolation.

For those in attendance, these talks did indeed demonstrate the bridges being built between research labs and industrial applications in the life sciences. Many thanks to Dr. Trout and Dr. Chatterjee for taking time out of their busy schedules to enlighten and inspire us; to our co-sponsor, the MIT Professional Institute; and to Educational Program Committee Chair Dave Novak and the EPC for organizing this event. 

AstraZeneca Hosts Labs21 Training Session in Waltham

by Chris Leary, KlingStubbins

By their nature, laboratory buildings with once-through ventilation air, high plug and process loads, and 24x7 operating hours leave a large environmental footprint.  Even with increased demands to reduce operating costs and environmental impacts, laboratory designers, owners, builders and operators are challenged to find innovative new ideas, case studies of best practices and benchmark building performance data to inform new buildings and renovations.

Laboratories for the 21st Century, or Labs21, a program co-sponsored by the Environmental Protection Agency (EPA) and the Department of Energy (DOE) , is dedicated to the pursuit of sustainable, high performance and low-energy laboratories that will minimize overall environmental impacts, protect occupant safety, optimize whole building efficiency on a life-cycle basis, establish goals, track performance and share results for continuous improvement.

On April 6 ^th the ISPE Boston Area Chapter, in partnership with the Boston R&D Network of the International Facilities Management Association (IFMA), National Grid and the University of Massachusetts, held a Labs21 "Introduction to High-Performance, Low-energy Design" Training Session.  Topics covered included Planning and Programming High-Performance Laboratories, Energy Efficient Lab HVAC, Lighting and Daylighting, and Optimizing Ventilation Rates.  Just over 100 attendees, including laboratory owners, facilities and design & engineering professionals, and builders participated in this day-long event.

AstraZeneca graciously hosted the event at their recently expanded and LEED Gold Certified R&D campus in Waltham, a facility that demonstrates many of the design and operational practices recommended by Labs21 including minimal impact on surrounding natural ecosystems, energy and water conservation, sustainable construction materials, and a safe healthy indoor work environment. Additional information about Labs21 can be found at http://www.labs21century.gov/ . 

Biotech and Pharmaceutical Manufacturing Sustainability – New Efficiencies and Cost Savings

by Lee J. Ward, Rockwell Automation

On March 18th, an unusually bright and sunny spring evening welcomed attendees to the Royal Sonesta in Cambridge for another excellent Boston Area Chapter Educational Program. Our speaker, David March of Rockwell Automation, opened by launching a spirited and energetic fusillade, suggesting that the "cumulative brainpower surrounding us in Cambridge" may well have had this "old chestnut" and currently overused term "sustainability" on their collective minds from time to time. He went on to cite some profoundly disturbing facts and figures regarding the enormous waste typically associated with the manufacture of pharmaceuticals including a recent audit that reported that pharmaceutical manufacturing is the "least efficient of all chemical process industries." Judging by the nods of many in the audience, the attendees seemed to agree.

The calculation is a simple ratio: Kg Waste/Kg Product. According to David, it is not uncommon for a pharmaceutical product to see a ratio of 200:1 up to 800:1. Biopharma is even worse, with ratios of up to 10,000:1. He went on to say that this is not yet part of mainstream understanding within the industry; however, the quest for higher productivity and cost management is beginning to expose this "dirty secret." In other words, the landscape is changing. A number of European countries have already implemented "carbon taxing," one of a number of "green" initiatives aimed at controlling waste and emissions and generally favoring clean manufacturing practices. "Do we here in the US need to be concerned?" he asked, then answered his own question with a resounding "yes" and went on to explain why.

There is an indirect financial impact that will be realized once a US manufactured pharmaceutical product is exported, as an example, to France. In addition to the usual "landed" cost of goods in the form of duty, a "carbon tax" on imported goods will be applied. Now it becomes clear why we need to be concerned. In order to remain competitive, we need to take steps to reduce the "carbon footprint" associated with the manufacture of pharmaceutical products so that those taxes can be minimized.

How do we do that? One contributor to the carbon footprint is solvents. David loves talking about solvents (as was immediately evident) - in fact, solvent recovery is his specialty. He spends many days during the course of the year talking to companies that use a lot of solvent, including traditional pharmaceutical manufacturers.

Solvents are carbon-based. They are also expensive and tough to deal with once they have been used. Let's look at manufacturing costs again. You have the cost of the product ingredients, the cost of the process materials and the cost of manufacturing time. Solvents come under the cost of process materials. This is a double hit since first you have to buy them and then you have to dispose of them safely and cleanly. And solvents can be highly toxic. As an example, toluene escaping through a leak in a piping system once decimated the population of Bhopal, India. As you can imagine, a substance as dangerous and toxic as that will be very expensive to dispose of properly.

One answer to the disposal question could be, "Let's burn it to make heat and power." After all, solvents generally burn really well. Furthermore, using solvents for this purpose is seen as a green solution since they burn relatively cleanly and have a high calorific value. So that makes it a good solution, right? Not so fast. While the combustion of spent solvent (ie. solvent waste) to make steam that can provide heat and power may be a good use of process waste, it might not be the best answer. While you are disposing of the liquid solvent, the combustion process itself will be contributing to carbon emissions that require monitoring and scrubbing.

Look at it from yet another angle, that of the accountant. Environmentally responsible process people look at the good they are doing by producing energy through the "no-cost" disposal of spent solvent. Yet the accountant will happily tell you the ROI calculation is flawed since it overlooks the original cost of the fuel. You might argue that the fuel is free (since it is reutilized waste) but it is not. You see, solvent is expensive when you first purchase it. If you have a method of recovering a large percentage of that solvent once it is used in the process and then you burn the recovered solvent, you have just used a very expensive fuel, one far more expensive than oil or natural gas. In any case, this use of recovered solvent, now common, may cease in the future when emissions-based carbon taxing will be applied.

A much better answer is not to burn the solvent but to recycle it. Fractional distillation can be employed for this purpose. If, as in most biopharma processes, solvents are employed for the chemical stripping of elements, there is likely to be a voluminous amount used. This solvent tends to be used once, then burned or discarded. Today's modern methods of fractional distillation enable upwards of 92 percent of the virgin solvent to be reclaimed, then reused in the manufacturing process, over and over again. So don't burn it, recycle it, and use natural gas to produce steam - its more cost effective that way.

But wait. There are further efficiencies to be had in the quest for sustainable solutions. Ever heard of "pinch" analysis? While fractional distillation is an answer to recycling solvent, it is an inefficient process. Well, normally. David explained that by using pinch technology we can reduce the cost of running a distillation system by making use of available efficiencies. In basic terms, we harvest the differential between hot and cold processes within the distillation system and recover heat or cold. David illustrated the concept using a series of graphs which had attendees scribbling away at their note pads. For me it signaled that we in the industry have so much more to explore in terms improving manufacturing efficiency and minimizing environmental impact.

Thanks go to our speaker for an exceptionally well-organized and lucid introduction to a complex topic; and to Meeting Manager and Educational Program Committee Chair Dave Novak for an information-packed and enjoyable evening. 

A Perfectly (Long) Day - Chapter Ski Outing Tackles Sunday River

by Jim Grunwald, SciTech Builders, LLC  with photos by Chris Opolski, Alexion Pharmaceuticals

March 5th found the attendees at the Chapter's Annual Ski Outing making the long trek to Sunday River in Newry, Maine. Between the chartered bus and those that drove to  the event, over 50 Chapter Members and guests joined in. And how lucky they were! Everyone was treated to the best ski conditions of the winter - and perhaps the last 10 years - with every trail, marked or unmarked, full of great snow.

Event veterans joined with first-timers to celebrate the 10th anniversary of this Chapter favorite.

It was truly a rare day, with perfect bluebird conditions, temps in the high 20s and nary a breath of wind. Those with an adventurous streak were treated to powder stashes in the trees that one can usually only experience in a Warren Miller movie or perhaps hanging around the bar when the stories begin to fly. Despite the additional travel time associated with the trek to Maine, everyone was very stoked by the experience.

Sunday River provided the best ski conditions of the winter and picture-perfect weather for the 10th Annual Ski Outing.

Many people commented on the many newcomers at the event, which was celebrating its 10th year. This was in addition to many veterans who have attended every year since the first. We also had in attendance a half-dozen members of the Chapter's very successful Young Professionals group, along with a very diverse group of ISPE Members and their guests.

Special thanks to Chapter Member and Event Manager Gene Dennen and to Chris Opolski, Chapter Board of Directors & Social Programs Director, for another great Ski Outing. This year they got the weather just right! And remember to mark your calendars for the first Friday in March 2011, when the Chapter heads north again!

Boston Area Chapter Scores with Bio-Ball Sponsorship

by Marita King, MARITeK, Inc., with photos by joebrownphotos.com

Bio-Ball team members and volunteers filled the gym to overflowing.

 

 

 

 

 

 

 

 

 
It was a cold and sunny morning on Saturday, March 27th, as volunteers arrived in the early hours at a Cambridge gymnasium to prepare for the arrival of Special Olympics Massachusetts athletes and their biotech industry teammates for the sixth annual Bio-Ball basketball tournament.   Much of the set-up had already been done the previous evening by another team of volunteers, which left the morning focused on breakfast preparation, final set-up and organizing the basketball courts for the various skills challenges and play.

Boston Area Chapter members were a part of this effort, which pulled together one of the most successful Bio-Ball tournaments to date.  The Chapter Board of Directors approved a first-ever financial contribution in support of Bio-Ball, while Chapter members had the opportunity to participate as players and volunteers and experience this fundraising event first-hand.  As the CEO Free Throw sponsor, Chapter recognition was front and center following the Opening Ceremonies. Chapter President Sylvia Beaulieu, who was also on the Bio-Ball organizing committee, congratulated each free throw participant and handed out a small gift on behalf of the Chapter - a whistle with an ISPE lanyard.  Whistles were also presented to all Chapter Member volunteers at the event as appreciation for their participation.

Chapter President Sylvia Beaulieu with industry leaders who participated in the ISPE-sponsored CEO Free Throw event, a tournament favorite.

Following the CEO Free Throw event, and inspirational words from one of the Special Olympics Massachusetts Hall of Fame athletes, the tournament was officially underway.  At last the teams were sent off to play and put forth their own version of March Madness.  Participating industry teams included AMAG Pharmaceuticals, Archemix, Cubist Pharmaceuticals, Genzyme, Momenta Pharmaceuticals, Novartis Institute for Biomedical Research, PAREXEL International, Pfizer, Sepracor, Shire and Vertex Pharmaceuticals.

The event raised almost $85,000 for the Special Olympics Massachusetts, which is nearly half of their operating budget.  Sponsorships came from other service and supplier organizations that work with the biopharma industry as well as donations from participating teams and individuals.  The Shire team, headed by Team Captain and Chapter Board member Kevin Lynch was edged out by AMAG for top team fundraising honors. Sean Brown of Lantheus, a Chapter member, was credited as the top individual fundraiser.

The one-day tournament raised over $85,000 for the Massachusetts Special Olympics!

For those keeping score,  Genzyme came out on top in tournament play (and won the CEO Free Throw by a wide margin), but everyone was a winner - particularly the Special Olympics athletes with their hard work and determination - and all who participated and experienced their spirit, joy, and enthusiasm.   Boston Area Chapter Scores with Bio-Ball Sponsorship

“Vaporized Hydrogen Peroxide (VHP) Decontamination” Draws a Crowd in Cambridge

by David S. Allen, Allen Consulting, LLC with photos by Brian Hagopian, Mar Cor Purification

On Tuesday, February 23rd the Boston Area Chapter presented an educational program at the Royal Sonesta Hotel in Cambridge. Our presenters were Peter Harris, Director of Operations for B & V Testing and Larry Zanko, Project Manager with Steris Corporation. Each brought a career's worth of expertise to the evening's topic. Peter and the decontamination specialists at B & V Testing have executed hundreds of gaseous space decontaminations at life science facilities ranging from small pilot plants to full aseptic production and fill/finish facilities and have been using Vaporized Hydrogen Peroxide (VHP) technology since 2005. As a Project Manager for Steris, Larry collaborates with customers in the pharmaceutical and research industries to engineer application-specific solutions. His technical expertise includes extensive knowledge of multiple-effect water stills, pure steam generators, steam sterilizers, COP washing systems, and VHP generators.

After a brief introduction by David Allen, the evening's event manager from the Educational Program Committee, Peter took us through the history of VHP sterilization, a typical VHP process, effectiveness and equipment compatibility data, and two application case studies.

Educational Program Committee Member & Meeting Manager David Allen (left) with speakers Peter Harris (center) and Larry Zanko (right).

He explained that VHP sterilization was introduced in 1991 by the American Sterilizer Company for use in isolators where it is still the most popular method of sterilization. Since that time, the use of VHP has expanded to include room decontamination for both new facilities and remediation. It is also used in aseptic process environments and for product sterilization.

Peter next walked us through a typical VHP decontamination cycle with the phases being dehumidification, conditioning, decontamination and aeration. We learned that one of the appealing attributes of VHP is that when the process is finished, all that is left is water and oxygen. There are no toxic residues. He then went on to explain the extensive testing that has proven the efficacy of VHP against bacteria, viruses, molds and yeasts. There are prescriptive doses for contaminants and various ways to confirm the dosage that has been delivered including electronic sensors and chemical test strips.

Peter concluded by explaining the steps in planning and carrying out a VHP decontamination project and told us the stories of two actual decontamination procedures. The first case was the emergency sterilization of a 240,000 square foot pharmaceutical manufacturing facility to remedy a contamination. The space included bioreactor rooms and the VHP was injected directly into 65 rooms and the air handling systems. The second case was an 84,000 cubic foot pilot production facility with 28 rooms that were sterilized as a routine preventive measure during a facility shut down.

After a short break, Larry took the stage and described the different types of equipment available for VHP applications: modular and portable. He explained that for facilities of less than 10,000 cubic feet that do not require routine sterilization, portable equipment is typically used. Portable equipment requires the use of fans to ventilate the room after decontamination. For spaces up to 80,000 cubic feet, fixed modular equipment can be installed. This is particularly valuable for rooms that require frequent, routine decontamination and for rooms that are isolated and could be compromised by bringing portable equipment into the space. Modular systems are typically integrated with the HVAC system.

Larry then went on to describe several aspects of modular installations. Since VHP passes through HEPA filters and sterilizes them, they need not be removed for decontamination. He also told us about the two cycles, single-pass and recirculating. In single-pass systems, the decontamination phase occurs while the HVAC system is shut down; in a recirculating system, the HVAC system continues to circulate air. In both cases, the HVAC is used to exhaust the air during the aeration phase. In concluding, Larry summarized the benefits of VHP compared to other sterilization techniques that can leave toxic residues.

The presentations were followed by a flurry of questions from the audience, the answers to which helped to further round out the presentations. A final thank you to Larry and Peter for their excellent technical presentations and to Claire Fritz of Steris whose behind-the-scenes efforts helped to organize the joint presentation between Steris and B&V.

Genzyme Hosts Young Professionals Educational Program

by Dan Ramsey, Commissioning Agents, Inc. with photo by Jim Landers, Wentworth Institute of Technology

The ISPE Boston Area Young Professionals group was recently formed to serve the professional needs of individuals who are establishing their careers in the biotechnology and pharmaceutical industry. The primary focus of this group is education, career/professional development and networking. On January 21st, the Young Professionals held its most recent educational event, sponsored by Genzyme at their corporate headquarters at 500 Kendall Street in Cambridge. The event was a great opportunity for young professionals, students and those new to the biotechnology and pharmaceutical industry to meet with experienced professionals and at the same time brush up on the basics in two areas, Process Analytical Technology (PAT) and bioreactor operations.

Genzyme provided an impressive and comfortable venue for the Young Professionals educational program.

The first presentation, on PAT, was entitled "Process Analytical Technology: What it is and Why it is the Future of Process Engineering, Validation and Quality" and was given by Lou Traglia of Commissioning Agents.  Lou gave a thorough explanation of PAT including an overview of the FDA guidance, PAT process control, how PAT is used in other industries and its future in the biotechnology and pharmaceutical industries. The seminar ended with an excellent question and answer series on the current roadblocks and issues with implementing PAT.

The second presentation, "Bioreactors: Making Sense of the Requirements, Operations and the Utilities They Require" was given by Aarash Navabi who works for Invensys and specializes in the operation, commissioning and validation of bioreactors and their support systems.  Aarash focused on the basics of bioreactors, including the different types of bioreactors, their design and construction, their monitoring requirements and the types of instruments required, and the basics of CIP and SIP operations. Aarash gave the audience an in-depth understanding of bioreactors and their requirements for efficient and effective operation.

The Young Professionals appreciate the support they receive from industry professionals who are willing to share their experience and knowledge and extend special thanks to Genzyme for sponsoring this event.   

The ISPE Boston Area Young Professionals group was recently formed to serve the professional needs of individuals who are establishing their careers in the biotechnology and pharmaceutical industry. The primary focus of this group is education, career/professional development and networking. On January 21st, the Young Professionals held its most recent educational event, sponsored by Genzyme at their corporate headquarters at 500 Kendall Street in Cambridge. The event was a great opportunity for young professionals, students and those new to the biotechnology and pharmaceutical industry to meet with experienced professionals and at the same time brush up on the basics in two areas, Process Analytical Technology (PAT) and bioreactor operations.

Genzyme provided an impressive and comfortable venue for the Young Professionals educational program.

The first presentation, on PAT, was entitled "Process Analytical Technology: What it is and Why it is the Future of Process Engineering, Validation and Quality" and was given by Lou Traglia of Commissioning Agents.  Lou gave a thorough explanation of PAT including an overview of the FDA guidance, PAT process control, how PAT is used in other industries and its future in the biotechnology and pharmaceutical industries. The seminar ended with an excellent question and answer series on the current roadblocks and issues with implementing PAT.

The second presentation, "Bioreactors: Making Sense of the Requirements, Operations and the Utilities They Require" was given by Aarash Navabi who works for Invensys and specializes in the operation, commissioning and validation of bioreactors and their support systems.  Aarash focused on the basics of bioreactors, including the different types of bioreactors, their design and construction, their monitoring requirements and the types of instruments required, and the basics of CIP and SIP operations. Aarash gave the audience an in-depth understanding of bioreactors and their requirements for efficient and effective operation.

The Young Professionals appreciate the support they receive from industry professionals who are willing to share their experience and knowledge and extend special thanks to Genzyme for sponsoring this event. 

Biotech Process Scale-up & Tech Transfer: Everything You need to Know for Success the First Time

article & photos by Joyce Chiu, Perceptive Informatics

On January 26th, on a cold winter evening, nearly 70 ISPE members and guests visited the beautiful Boston Seaport facility of the law firm Foley Hoag to network and listen to three experienced industry practitioners share their experiences on "Biotech Process Scale-up & Technology Transfer," a topic central to the development and manufacture of pharmaceutical drug substances.

The attendees first enjoyed some wonderful appetizers and informal networking.  Many area biotech engineers showed up, with a higher-than-usual number of women and young professionals.  Many also lingered after the formal program ended and continued networking.

What a Process Technology Transfer Needs to Accomplish: Hurdles and Techniques

Jeff S. Socolow, MBA, Sr. Project Manager, Shire Human Genetic Therapies

Jeff opened the evening by providing a general overview of technology transfer - its definition, guiding principles, governance structure, project structure, requirements and pitfalls of the originating and receiving organizations, as well as other considerations.

Process tech transfer is the faithful and compliant transfer of technology, information, documentation and skills from the process owner (the originating organization) to a GMP manufacturing organization (the receiving organization).  A tech transfer has the best chance of success with

• minimal equipment and process changes,
• early partnership with Quality,
• established governance structure,
• extensive planning, and
• team-owned decisions.

A tech transfer consists of five to eight stages and starts with a rigorous facility fit assessment to identify equipment compatibility and gaps at the receiving organization. Included in the assessment are: readiness to establish standards of product quality and productivity, scale (lab or pilot) and considerations for manufacturability.

A tech transfer governance structure consists of an organizational chart where roles and responsibilities are defined; and a gated, stage-based process map with deliverables for each stage, from which a detailed project schedule can be developed.

A breathtaking view from the 13th floor of the Foley Hoag Seaport facility greeted attendees

For the originating organization, having an accurate and locked-down process description (both upstream and downstream) is critical.  Typically the downstream process tends to lag behind the much longer upstream process.  Where external CMOs are involved, sometimes not all the issues can be anticipated; therefore upfront due-diligence and risk assessment and management are all that much more important.

For the receiving organization, assessing their process capability, facility fit and risks; and locking down the bill of materials as early as possible are key.  Some common pitfalls include automation issues, the time it takes to finalize documentation, and training of operators.

The key factors for a successful tech transfer include an approved project scope and plan, effective meeting management, anticipating issues while keeping governance apprised, a detailed and baseline schedule, team ground rules and holding members accountable, standard reporting and collaboration tools, and a well-defined communication strategy.

Technology Transfer: What You Need Before You Start ... and Probably Don't Have

Sheila G. Magill, PhD, BioProcess Technology Consultants

Sheila continued with a definition, kinds of tech transfers, protocols, materials and knowledge.  The definition echoes what Jeff shared - a process transferred from one organization to another, whereby the same results and outcome are achieved.

There are process transfers and analytical method transfers.  In analytical method transfers, it is important to define the critical raw materials, not only going by the vendor's QC methods and release criteria, but also by how they are used in the particular process, that is, their fitness-for-use.

Risk management is an important consideration in tech transfer.  In early clinical stages, it may not be critical, or even desirable, to use cGMP rigor because the process and analytics are still early in their development.  As the process gets closer to late stage and cGMP manufacture, the rigor and compliance to cGMP standards become more important and must be adhered to.

Tech transfers require a clear description of the process or method, deep knowledge about the process in documentation form, materials to enable the transfer, and what constitutes a successful transfer.  These will enable the receiving organization to replicate the results of the originating organization.  In the transfer protocol, there needs to be a clear definition of responsibilities, equipment, materials, activity and personnel. 

In addition, to allow a smooth knowledge transfer, frequent meetings and exchange of information are required, which can consume a lot of time and resources, and the commitment and goodwill of both parties.  These entail the commitment of senior management to provide necessary resources, the need for clear and realistic timetable and a plan.

Tech Transfer from Development to cGMP Manufacture: Challenges & Solutions in Scaling up a New Microbial Process from 5L to 1000L+

Susan Dana Jones, PhD, BioProcess Technology Consultants

Susan concluded the evening by sharing a detailed case study of a microbial process scale-up from 5L to 1000L+.  Because of the large gap in equipment scale and the fact that microbial processes are developed individually, this tech transfer must include detailed assessments of each unit operation, their performance requirements and any variance noted during development.

The audience payed close attention during the evening's presentations.

This SynCo process scale-up has multiple unit operations in both upstream and downstream processes.  The upstream processes at 5L scale include: pre-culture (shake flask), fermentation, cell disruption, batch centrifuge, depth filtration and ultra-filtration.  The downstream processes include cation exchange chromatography, ultrafiltration, gel filtration (fractionation), 0.22 μm filtration and bulk fill.

During process development, tech transfer considerations were included.  Established E.coli fermentation medium, conditions, etc. compatible with the large scale facility were used.  There were no animal-derived media components and no complex feeds or supplements other than pH and dO ₂ control.  In addition, knowledge of facility operations at the larger scale influenced process development choices at the 5L scale - a simple fermentation batch operation was used with minimal downstream steps while achieving product quality and purity, as well as half of the fermentation culture was used for downstream processing at scale.

During scale-up, all operating parameters at 5L scale were verified with three batches prior to an engineering batch at scale.  The raw materials intended at scale were used in process development.  Scale-up for chromatography and filtrations steps was linear; fractions in chromatography steps were collected to allow flexible pooling strategy at scale.  In addition, breakthrough studies at small scale can support the choice of filter area at large scale.

With the above strategies in place, the volumes and times between the two scales were established, with good reproducibility at both, while the 1000L scale cell growth, as indicated by optical density, was not as good as at 5L, because of the challenges of effective heat transfer at the large scale.  All of the unit operations showed good to excellent scaleability results, with the exception of centrifugation, because that process is a batch process at 5L and a continuous process at 1000L.

This case study exemplifies some of the best practices used in process development and tech transfer, where the development at the small scale incorporated many careful considerations and minimized risks at the larger scale.

By the end of the evening, attendees not only had a good idea of the general framework and guiding principles of process scale-up and tech but had enjoyed a riveting case study where success was clearly demonstrated. Several area biotech engineers expressed interest in learning more about tech transfer, in particular the best practices in risk management from early to late stage development, as well as new technologies for the unit operations used in bioprocess manufacturing.   

On January 26th, on a cold winter evening, nearly 70 ISPE members and guests visited the beautiful Boston Seaport facility of the law firm Foley Hoag to network and listen to three experienced industry practitioners share their experiences on "Biotech Process Scale-up & Technology Transfer," a topic central to the development and manufacture of pharmaceutical drug substances.

The attendees first enjoyed some wonderful appetizers and informal networking.  Many area biotech engineers showed up, with a higher-than-usual number of women and young professionals.  Many also lingered after the formal program ended and continued networking.

What a Process Technology Transfer Needs to Accomplish: Hurdles and Techniques

Jeff S. Socolow, MBA, Sr. Project Manager, Shire Human Genetic Therapies

Jeff opened the evening by providing a general overview of technology transfer - its definition, guiding principles, governance structure, project structure, requirements and pitfalls of the originating and receiving organizations, as well as other considerations.

Process tech transfer is the faithful and compliant transfer of technology, information, documentation and skills from the process owner (the originating organization) to a GMP manufacturing organization (the receiving organization).  A tech transfer has the best chance of success with

• minimal equipment and process changes,
• early partnership with Quality,
• established governance structure,
• extensive planning, and
• team-owned decisions.

A tech transfer consists of five to eight stages and starts with a rigorous facility fit assessment to identify equipment compatibility and gaps at the receiving organization. Included in the assessment are: readiness to establish standards of product quality and productivity, scale (lab or pilot) and considerations for manufacturability.

A tech transfer governance structure consists of an organizational chart where roles and responsibilities are defined; and a gated, stage-based process map with deliverables for each stage, from which a detailed project schedule can be developed.

A breathtaking view from the 13th floor of the Foley Hoag Seaport facility greeted attendees

For the originating organization, having an accurate and locked-down process description (both upstream and downstream) is critical.  Typically the downstream process tends to lag behind the much longer upstream process.  Where external CMOs are involved, sometimes not all the issues can be anticipated; therefore upfront due-diligence and risk assessment and management are all that much more important.

For the receiving organization, assessing their process capability, facility fit and risks; and locking down the bill of materials as early as possible are key.  Some common pitfalls include automation issues, the time it takes to finalize documentation, and training of operators.

The key factors for a successful tech transfer include an approved project scope and plan, effective meeting management, anticipating issues while keeping governance apprised, a detailed and baseline schedule, team ground rules and holding members accountable, standard reporting and collaboration tools, and a well-defined communication strategy.

Technology Transfer: What You Need Before You Start ... and Probably Don't Have

Sheila G. Magill, PhD, BioProcess Technology Consultants

Sheila continued with a definition, kinds of tech transfers, protocols, materials and knowledge.  The definition echoes what Jeff shared - a process transferred from one organization to another, whereby the same results and outcome are achieved.

There are process transfers and analytical method transfers.  In analytical method transfers, it is important to define the critical raw materials, not only going by the vendor's QC methods and release criteria, but also by how they are used in the particular process, that is, their fitness-for-use.

Risk management is an important consideration in tech transfer.  In early clinical stages, it may not be critical, or even desirable, to use cGMP rigor because the process and analytics are still early in their development.  As the process gets closer to late stage and cGMP manufacture, the rigor and compliance to cGMP standards become more important and must be adhered to.

Tech transfers require a clear description of the process or method, deep knowledge about the process in documentation form, materials to enable the transfer, and what constitutes a successful transfer.  These will enable the receiving organization to replicate the results of the originating organization.  In the transfer protocol, there needs to be a clear definition of responsibilities, equipment, materials, activity and personnel. 

In addition, to allow a smooth knowledge transfer, frequent meetings and exchange of information are required, which can consume a lot of time and resources, and the commitment and goodwill of both parties.  These entail the commitment of senior management to provide necessary resources, the need for clear and realistic timetable and a plan.

Tech Transfer from Development to cGMP Manufacture: Challenges & Solutions in Scaling up a New Microbial Process from 5L to 1000L+

Susan Dana Jones, PhD, BioProcess Technology Consultants

Susan concluded the evening by sharing a detailed case study of a microbial process scale-up from 5L to 1000L+.  Because of the large gap in equipment scale and the fact that microbial processes are developed individually, this tech transfer must include detailed assessments of each unit operation, their performance requirements and any variance noted during development.

The audience payed close attention during the evening's presentations.

This SynCo process scale-up has multiple unit operations in both upstream and downstream processes.  The upstream processes at 5L scale include: pre-culture (shake flask), fermentation, cell disruption, batch centrifuge, depth filtration and ultra-filtration.  The downstream processes include cation exchange chromatography, ultrafiltration, gel filtration (fractionation), 0.22 μm filtration and bulk fill.

During process development, tech transfer considerations were included.  Established E.coli fermentation medium, conditions, etc. compatible with the large scale facility were used.  There were no animal-derived media components and no complex feeds or supplements other than pH and dO ₂ control.  In addition, knowledge of facility operations at the larger scale influenced process development choices at the 5L scale - a simple fermentation batch operation was used with minimal downstream steps while achieving product quality and purity, as well as half of the fermentation culture was used for downstream processing at scale.

During scale-up, all operating parameters at 5L scale were verified with three batches prior to an engineering batch at scale.  The raw materials intended at scale were used in process development.  Scale-up for chromatography and filtrations steps was linear; fractions in chromatography steps were collected to allow flexible pooling strategy at scale.  In addition, breakthrough studies at small scale can support the choice of filter area at large scale.

With the above strategies in place, the volumes and times between the two scales were established, with good reproducibility at both, while the 1000L scale cell growth, as indicated by optical density, was not as good as at 5L, because of the challenges of effective heat transfer at the large scale.  All of the unit operations showed good to excellent scaleability results, with the exception of centrifugation, because that process is a batch process at 5L and a continuous process at 1000L.

This case study exemplifies some of the best practices used in process development and tech transfer, where the development at the small scale incorporated many careful considerations and minimized risks at the larger scale.

By the end of the evening, attendees not only had a good idea of the general framework and guiding principles of process scale-up and tech but had enjoyed a riveting case study where success was clearly demonstrated. Several area biotech engineers expressed interest in learning more about tech transfer, in particular the best practices in risk management from early to late stage development, as well as new technologies for the unit operations used in bioprocess manufacturing. 

ISPE Teams with MDG for Career Development Workshops

by Bob Urbanowski, TUV Rheinland and Kimberly Simpson with photos by Joyce Chiu, Perceptive Informatics

January 12th was a first for the ISPE Boston Area Chapter and MDG (Medical Development Group) - an evening of jointly-sponsored Career Management Workshops presented for the benefit of members of both organizations. In addition to the timely information presented, attendees benefited from a chance to mix and mingle with members of an allied organization, adding a new dimension to the traditional networking reception. 

Presenters Bob Vear and Linda Trowbridge of Change Dynamics, Inc.

The evening provided something for everyone with its dual focus on 1) succeeding in your current job and 2) conducting a successful job search. With two sessions each, both "tracks" were presented by professional career consultants, the first by Carol Bergeron of Bergeron Associates and the second by Bob Vear and Linda Trowbridge of Change Dynamics.

Survive and Thrive by Staying Put

In the "Survive and Thrive by Staying Put" workshop, Carol provided practical approaches for managing your career. Through interactive exercises, participants identified their ideal corporate culture by examining the positive features of past achievements.  To identify opportunities for career growth and advancement, participants tried to align their talents and preferences with their organizations' goals. Based on this understanding, participants learned techniques to pave the way for advancement by taking charge of their own development and promoting their unique skills and achievements.

Chapter Past President Doyle Johnson chats with attendees during the networking reception.

Crack the Code on Networking

The "Crack the Code on Networking" workshop introduced participants to the value of relationships and the techniques for building and strengthening them. Carol shared a Targeted Networking Technique to enhance networking value by working with your existing contacts to build relationships and utilizing them to expand your network.  She also described how to request and conduct an effective informational interview and how to work a networking event.  To achieve networking benefits, Carol emphasized the importance of helping others - in other words, in order to be fully effective, networking must be approached as a two-way street.

Resume Best Practices

Meeting Manager Ric Feldt with presenter Carol Bergeron of Bergeron Associates.

The number one piece of advice was to keep your resume updated. Like batteries in a smoke detector, you should probably dust yours off twice a year to keep the document current with your latest accomplishments and acquired skills. If your resume is terribly outdated, the chore starts with some introspective soul-searching. Simply put, you must be able to articulate how you have helped former employers gain business success and what you want to do next.

Beyond the basic tenet that the resume should be either in functional or chronological format, it's pretty much open game on layout and content. And here's where many professionals get sidetracked. According to Linda and Bob, most job seekers stumble by trying to build an all-inclusive shopping list of their lifelong responsibilities, employment history and relevant education, associations, etc. Unfortunately, this approach is not likely to help the candidate reach their goal, which is to get an interview.

Instead, the resume should be viewed as a piece of "sales" literature, with the "product" being pitched: you. The key take-aways from this session were: keep all descriptions crisp and brief, include quantitative results of your achievements and customize it for each type of position being sought or, better yet, for every position.

How to Conduct an Effective Job Search

Patrick Sharp and his daughter Whitney both found the workshops filled with useful information.

Recent studies have shown that almost 60 percent of all jobs found today are found through networking. That means the use of networking goes beyond just a LinkedIn profile and a diligent scrub of those 1982 spring break photos from your frat brother's Facebook page. To be most effective, job seekers need to be mindful of their career aspirations at all sorts of social events, such as church coffee hours and even in line at the grocery store.

Linda and Bob recommended that job seekers be mindful of professional decorum and do not ignore the "human touch" in exchange for digital efficiency. They also explained that the tough economy has made the recruiter even more valuable since employers are more determined than ever to fill every opening with the best candidate available. The recruiter can provide information about the hiring landscape and invaluable coaching, including "reading between the lines" in the job description to identify candidate must-haves. Ultimately all of that ups the odds of a successful match between candidate and position.

In the words of one attendee, "Although I went through a job change about a year ago and thought that I knew it all, it was still good to get the key points reinforced. Linda and Bob did a great job by dispensing real-world advice and not sugar-coating the realities of today's job market."   

January 12th was a first for the ISPE Boston Area Chapter and MDG (Medical Development Group) - an evening of jointly-sponsored Career Management Workshops presented for the benefit of members of both organizations. In addition to the timely information presented, attendees benefited from a chance to mix and mingle with members of an allied organization, adding a new dimension to the traditional networking reception. 

Presenters Bob Vear and Linda Trowbridge of Change Dynamics, Inc.

The evening provided something for everyone with its dual focus on 1) succeeding in your current job and 2) conducting a successful job search. With two sessions each, both "tracks" were presented by professional career consultants, the first by Carol Bergeron of Bergeron Associates and the second by Bob Vear and Linda Trowbridge of Change Dynamics.

Survive and Thrive by Staying Put

In the "Survive and Thrive by Staying Put" workshop, Carol provided practical approaches for managing your career. Through interactive exercises, participants identified their ideal corporate culture by examining the positive features of past achievements.  To identify opportunities for career growth and advancement, participants tried to align their talents and preferences with their organizations' goals. Based on this understanding, participants learned techniques to pave the way for advancement by taking charge of their own development and promoting their unique skills and achievements.

Chapter Past President Doyle Johnson chats with attendees during the networking reception.

Crack the Code on Networking

The "Crack the Code on Networking" workshop introduced participants to the value of relationships and the techniques for building and strengthening them. Carol shared a Targeted Networking Technique to enhance networking value by working with your existing contacts to build relationships and utilizing them to expand your network.  She also described how to request and conduct an effective informational interview and how to work a networking event.  To achieve networking benefits, Carol emphasized the importance of helping others - in other words, in order to be fully effective, networking must be approached as a two-way street.

Resume Best Practices

Meeting Manager Ric Feldt with presenter Carol Bergeron of Bergeron Associates.

The number one piece of advice was to keep your resume updated. Like batteries in a smoke detector, you should probably dust yours off twice a year to keep the document current with your latest accomplishments and acquired skills. If your resume is terribly outdated, the chore starts with some introspective soul-searching. Simply put, you must be able to articulate how you have helped former employers gain business success and what you want to do next.

Beyond the basic tenet that the resume should be either in functional or chronological format, it's pretty much open game on layout and content. And here's where many professionals get sidetracked. According to Linda and Bob, most job seekers stumble by trying to build an all-inclusive shopping list of their lifelong responsibilities, employment history and relevant education, associations, etc. Unfortunately, this approach is not likely to help the candidate reach their goal, which is to get an interview.

Instead, the resume should be viewed as a piece of "sales" literature, with the "product" being pitched: you. The key take-aways from this session were: keep all descriptions crisp and brief, include quantitative results of your achievements and customize it for each type of position being sought or, better yet, for every position.

How to Conduct an Effective Job Search

Patrick Sharp and his daughter Whitney both found the workshops filled with useful information.

Recent studies have shown that almost 60 percent of all jobs found today are found through networking. That means the use of networking goes beyond just a LinkedIn profile and a diligent scrub of those 1982 spring break photos from your frat brother's Facebook page. To be most effective, job seekers need to be mindful of their career aspirations at all sorts of social events, such as church coffee hours and even in line at the grocery store.

Linda and Bob recommended that job seekers be mindful of professional decorum and do not ignore the "human touch" in exchange for digital efficiency. They also explained that the tough economy has made the recruiter even more valuable since employers are more determined than ever to fill every opening with the best candidate available. The recruiter can provide information about the hiring landscape and invaluable coaching, including "reading between the lines" in the job description to identify candidate must-haves. Ultimately all of that ups the odds of a successful match between candidate and position.

In the words of one attendee, "Although I went through a job change about a year ago and thought that I knew it all, it was still good to get the key points reinforced. Linda and Bob did a great job by dispensing real-world advice and not sugar-coating the realities of today's job market." 

The Tradition Continues: Another Great Holiday Party at Flat Top Johnny’s

by Janet Tice, GMP Piping with photos by Joyce Chiu, Perceptive Informatics

Now an ISPE Boston Area Chapter tradition, the Holiday Social was held at Flat Top Johnny's Billiards in Kendall Square on January 14th. This year we had our biggest turnout ever - well over a hundred guests from a cross-section of the Chapter's membership - with operating companies, academic and research institutions, vendors and contractors all well represented. Perhaps even more important, attendees were more enthusiastic than ever before - definitely in a mood to party with friends, dig into the hearty food and drink, and share a round of billiards with their ISPE cronies.

And once again, the Chapter proved it does a wonderful job of bringing members together to share information with contacts both old and new. The buzz of conversation regarding the latest what's what and who's who in the local life sciences community was a great reminder that networking with peers is vital in these difficult times, with the economy weak and the job outlook uncertain.

In addition to the food, drink and conversation, there were fantastic prize giveaways sponsored by A/Z Corp, Aztec Technologies, Columbia Construction, CRB Consulting Engineers, Spectra Automation and Ultrafiltronics. Plus the Social was a benefit for the Care Package Project sponsored by MarineParents.com, with attendees donating requested items such as single-use cameras, toiletries, batteries and food items for shipment to marines in Iraq and Afghanistan.

Many thanks to the sponsors of this event and to the many hard-working Chapter volunteers who made this tremendous night possible.  Kudos to you! We're already looking forward to next year!