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Great Turnout Makes the Ski Outing One for the Record Book!

by Jim Grunwald, DPS, with photo by Kristen Dangelo, Boston Analytical

The 2016 edition of the Chapter's Annual Ski Outing is in the record book - we had a great day at Waterville Valley, NH on March 4. Attendees were blessed with fine weather and great camaraderie in an excellent setting for networking with peers and sharing news from the industry. Attendance for the day was 62, a great milestone for the event and the Chapter.

Started 16 years ago, the first Annual Ski Outing was attended by six skiers! They had a shared vision of starting something new in format that fostered fun and created a place for clients and service providers to enjoy each other's company. The idea was based on providing an informal environment in the great outdoors. This mission has surely been accomplished as all attendees thoroughly enjoyed the day and the networking.

As with many of our other Chapter initiatives, the Social Committee has a charitable bent. We are happy to announce that this year's Ski Outing raised $1000 for the Dana Farber Cancer Institute and are very pleased to have had the support of our attendees in reaching this milestone.

A special thanks to all of our sponsors: A/Z Corporation, Albireo Energy, Boston Analytical, CAI, Commodore Builders, DPS, JENSEN HUGHES, Reflex Lighting, RW Sullivan, Sentrol, Superior Controls and TRIA; and finally to Kristen Dangelo of Boston Analytical and Jim Grunwald of DPS for organizing and running this event.

Looking ahead, the Social Committee has a very ambitious program for the balance of the spring and summer. Next up, on May 9, we have the Spring Golf Outing at Ledgemont Country Club in Seekonk. This will be followed by the Summer Social and Volunteer Appreciation with a tropical luau beach party theme at the Squantum Yacht Club in Quincy on June 23 and the ever-popular Summer Golf Outing at Lake Winnipesaukee Golf Club in New Durham, NH on August 8. 

The Committee would like to invite Chapter Members to consider joining as a volunteer to help plan and coordinate these events. We have an excellent group of people dedicated to providing fun, uplifting and meaningful events for our Members. Just bring your energy and your ideas!

 

Genzyme Hosts Presentation on Facility Expansions in Operating Plants

by Rose Mary Su, Acentech, with photos by Joyce Chiu, Shire

The ISPE Boston Area Chapter held a successful educational event this past February on the popular topic of how to renovate and expand an existing plant without shutting down. The presentation, entitled "Dancing through Traffic: Facility Expansions in Operating Plants," drew over 60 attendees to Genzyme in Cambridge.

The evening began with a networking reception at Genzyme's atrium space with great appetizers and drinks. It was great to see a lot of familiar faces as well as new faces in the crowd ranging from process engineers, facility managers, students and engineers to specialty consultants. Similar receptions were held at remote sites - WPI in Worcester and the Crowne Plaza in Warwick, RI - where attendees were able to watch a live telecast of the presentation. In addition, the Red Hook Brewery in Portsmouth, NH was pilot-tested for use as a remote site for future broadcasts. Thanks to Aaron Babcock of Zetawave Productions for coordinating with the Genzyme tech team to stream this presentation.

Veteran presenters and subject matter experts Rick Kotosky (right)...

 

...and John Spohn (second from right) found a few moments to chat with fellow Members during the networking reception. 

The presentation was extremely informative while being entertaining at the same time. Presenters John Spohn and Rick Kotosky, both from Hargrove, are great speakers and have presented on this topic at past ISPE events. They opened with a video of a family of ducks and ducklings crossing a busy, six-lane interstate highway as an analogy to the plant renovation process. The audience was entertained but also got their message about how complicated and challenging a process this can be. The speakers took turns throughout the presentation, which kept the discussion lively, and their relaxed, conversational delivery made the wealth of information they presented easy to digest.


Undoubtedly there are a lot of challenges that come with the desire to avoid shutting down a plant in production while carrying out an expansion or renovation. The need for expansion or renovation can potentially interfere with production schedules, introduce unanticipated elements such as noise and vibration from construction and, as a result, increase the duration and cost of a project. The typical approach would be to move as quickly as possible to limit interruptions in current products. What the speakers wanted is for us to take a step back and understand the owner's needs and prioritize typical key concerns such as limiting production interruptions, developing a high-confidence schedule and eliminating adverse effects on processes under modification, products concurrently in-process and regulatory filings.

The speakers provided useful advice on how to keep both the operation and renovation running smoothly but one of the most important take-home messages is to consult experts that are familiar with the challenges and can raise potential concerns early in the planning and design stages so that surprises can be avoided and neither construction nor on-going production delayed or disrupted. They suggested a dramatic shift in the approach to the planning and implementation phases with a strong emphasis on thoughtful feasibility study, planning and evaluation of options as methods ensuring a successful renovation and expansion.

A lively question and answer session followed the presentation. The audience had many excellent questions for both presenters, attesting to the high level of interest in the subject matter. Not only did the presenters receive numerous questions from the audience in Cambridge, they also got questions from the remote sites via Mailinator. These questions were relayed to the presenters by the meeting managers on behalf of the off-site attendees, a process which worked quite well, making it an interactive Q&A session for everyone, no matter where they were located.

This educational program is the last to be hosted by Genzyme Cambridge. We want to thank Genzyme for their generous support of the Boston Area Chapter over a period of several years. The Chapter would also like to thank our speakers for their wonderful presentations, our hosts at Genzyme and WPI, the meeting managers who coordinated the event, the staff at CAMI and everyone else who helped make the evening a great success. And lastly we would like to thank program sponsor Commissioning Agents (CAI) for their ongoing support for the Chapter's educational programs.

Members Gather at Shire for Pilot Plant Tour and Panel Discussion

by Stacy Price, Shire, with photos by Joyce Chiu, Shire

The Boston Area Chapter educational program, "Learning Through Doing: The Interplay of Pilot Plant, Product and Process," took place on Thursday, March 24 at Shire's Pharmaceutical Development and Pilot Plant facility in Lexington, MA. The discussion was both comprehensive and engaging, with the panel and moderator describing the pilot plant as a key step in scaling processes from development to manufacturing. They explained that if you look closely and leverage the capabilities and opportunities, the pilot plant can be a lot more than just material production. It is where operations are refined for larger scale production - which is not as easy as it may sound.

Between the pilot plant tour, the Young Professional's round table with the panelists and the panel discussion and Q&A session to follow, the evening promised - and delivered - lots of stimulating conversation on an important topic central to our industry.

YPs turned out in force to attend a round table with the panelists designed just for them.

While the 100+ attendees enjoyed an opening reception with conversation and appetizers, Elisa Pepicelli and Mirza Zukic from Shire guided attendees through Shire's Pilot Plant suites to see how toxicology and development material is made. Included were single use perfusion bioreactors, single use centrifugation and ATF (alternating tangential filtration) for cell separation, UF/DF and chromatography equipment.

Chapter Past Presidents Mark Sitcoske (l) and Andre Walker (r) share a light moment during the networking reception.


Following the reception and tour, Stacy Price of Shire opened the program by introducing the role of the pilot plant in the product life cycle and Moderator Brad Ebel of Shire introduced the five panelists: Bill Brazier of Amgen, Christof Schulz of Abbvie, Kelly Wiltberger of Biogen, David Sullivan of Pfizer and Shaun Grier of Shire. Each panelist then described their background, their role in the pilot plant and their respective companies.

Moderator Brad Ebel of Shire (l) introduced the five panelists (l to r):  Christof Schulz of Abbvie,  Bill Brazier of Amgen, Kelly Wiltberger of Biogen, David Sullivan of Pfizer and Shaun Grier of Shire.

Brad presented the data collected from a benchmarking study across the five company sites represented. The benchmarking was performed to understand the focus of biological processing pilot plants in the Boston area. Areas of commonalty are that all companies focus on team supply and demonstration runs, use disposable systems, and are involved in technology development and design/scalability of processes. Areas of differences included the modality of product produced (monoclonal antibodies, enzymes, etc.), the degree to which operations range finding was performed, whether or not training was provided to manufacturing groups, and whether or not solution preparation services were included.

The pilot plant of the future was the next topic of conversation. Brad presented the "pilot plant of the future mission statement" developed at the Pilot Plant Industrial Network Forum:

"We are a cutting edge, variable scale Pilot Plant Facility with capabilities ranging across multiple technology and modality platforms. We aim to stay ahead of our customers' growing, diverse needs by continually seeking out and implementing the newest technologies and advances in industry to enable readiness for manufacturing whenever needed."

Agility is a key aspect of pilot plant success. One doesn't always know what's in store when processing new proteins at large scale for the first time. Dave articulated that pilot plants have a huge opportunity and responsibility in demonstrating processes and establishing robustness, training, and ensuring successful technology transfer and manufacturing as new technologies scale out and up. Kelly suggested that the facilities be designed to have flex spaces with a modular approach to utilities, equipment (portable vs. fixed) and automation support. Bill noted that in addition to pilot plant operations, a diversity of resource skills is required such as automation engineering expertise, scientific knowledge and quality system understanding.

GMP is a frequent consideration for pilot plants. It is usually desirable to have an in-house facility that can produce early clinical material for first in-human use. However, converting a pilot plant to a cGMP facility carries with it serious considerations because the agility of a plant under cGMP typically decreases. The panelists had an open conversation about the need for phase appropriate GMP, in the level of equipment validation and quality system oversight, for example. Shaun noted that phase appropriate GMP is the key to efficiently and effectively transitioning from toxicology to Phase I clinical production since the cost of developing a drug doubles every nine years. Christof stressed that producing GMP product in the same space as non-GMP product will require resources to be fully versed and adaptable to the quality requirements for the production run at hand. During the Q&A following the discussion, the audience had many excellent questions for the panel, attesting to the high level of interest in the subject matter.

The Chapter would like to thank our moderator and each of our panelists for their engaging and educational discussion, the staff at Shire who coordinated the event and tour, event sponsor Commissioning Agents (CAI) and everyone who helped make this event a great success!

 

YPs Keep Busy with a Full Calendar of Events

by Christopher Ciampa, Thermo Fisher Scientific with photos by Brody Stara, Amgen, and  Vaibhav  Shah, University of Massachusetts

Now that the weather is finally warming up, we have some great YP programs coming up. Read on for a quick look at the events we have hosted recently as well as a taste of what the spring and summer have in store.

At the end of March we had our first-ever YP roundtable, which was hosted as part of the educational program at Shire and brought the evening's panelists together with a group of about 20 YPs. The panelists were project engineers and seasoned professionals from operating companies such as Shire, Pfizer, Amgen, and Biogen. It was very informal and gave the panelists and attendees an opportunity to get to know each other and share information. Jillian Willard facilitated the discussion and got to ask the tough questions (such as what is tech transfer and why it's important for pilot plants to do it effectively). Everyone enjoyed the discussion, which was very lively and informative.

Since this first-of-its-kind event was so successful, we will use it as a "best practice" when organizing future educational events. A big thank you to the attendees, the panelists and everyone who helped make the event a success!

We held two social events in April. Based on the success of the bowling social last year, we headed back to Sacco's in Davis Square on April 7 for candlepin bowling and flatbread pizza. The format was similar to last year: an hour of networking and dinner (pizza/salad/dessert and beer on tap) followed by two hours of bowling. And again - in spite of the heavy downpour that day - the turnout was excellent

Pizza and beer at The Flatbread Company provided the energy needed for an evening of candlepin bowling at Sacco's in Somerville.

The second event - a Providence Bruins game - was another first. It was held south of Boston to attract Members of the former New England Chapter (which merged with the Boston Area Chapter in 2013). Although attendance was light, the event was a big success - the buffet was excellent, the atmosphere was great and the Bruins won! Word-of-mouth is sure to guarantee a healthy turnout for this event next year.

Chapter board member Jared Marshall with friend at the Providence Bruins game.

The theme for April's educational program was "Biomanufacturing Science & Technology, Preparing for Tomorrow." It was hosted at WPI and broadcast live to three remote sites (Cambridge, Portsmouth and Providence) as part of the Chapter's "GO" initiative. Attendance was good with students, young professionals and industry veterans all well-represented. Three speakers (Parrish Galliher, Philippe de Vilmorin and Prakash Rai) gave in-depth presentations which were followed by a panel discussion, with questions from the audience at WPI and all three remote sites. This year's Annual Student Poster Competition was held in conjunction with the educational program. Congratulations to our winners: Connor Williams, UMass Lowell (undergraduate); and John de la Parra, Northeastern (graduate); and thanks to our judges - two of whom were past winners - who worked hard to narrow the excellent field down to two.

As an aside - we are looking to partner up again with WPI again this fall - as they are having a 5-day seminar on bioreactors. We are exploring the possibility of an evening event in conjunction with the seminar so that students and YPs can see the bioreactors. More to come on this in the future...

Our annual Red Sox outing is in the works for Thursday, July 21. Come watch our fellow Sox take on the Minnesota Twins! There will be a pre-game event, most likely at "Who's on First," reopening after extensive renovations as "The Bullpen." The name may have changed but you can expect the same great food and pre-game venue!

Looking toward the end of 2016, we are planning a dual track educational program for November. One suggestion for the YP track is "Regulatory 101: Jargon for Engineers." It will be hosted in the Boston area, preferably at a local college site. We are hoping to have two speakers in tag-team approach, one from a consulting company and one from an operating company. We have a few months before the topic needs to be locked down, so if you have other suggestions, please let me know.

As always, we want to hear from you! If you have any suggestions, or would like to attend one of the regularly scheduled YP Committee meetings, please don't hesitate to reach out to me ( christopher.ciampa@gmail.com ). Happy Spring and go Red Sox!

 

Students Reap the Many Benefits of ISPE Membership

by Brian Hagopian, Clear Water Consulting, and Paige Kane, Pfizer

The Chapter's Student Members benefit in so many ways from their involvement with ISPE. Here are just a few of the advantages that membership offers this spring:

• Over 75 new postings for internships, co-op's and full time positions
• Two Shire plant tours in March
• On-Campus Career Fairs attended at UNH, UMass Lowell and WPI
• Student Poster Contest on April 20 
• Scholarship Applications due June 1

The Chapter has been extremely busy helping students find employment, whether it's a summer internship, co-op or full time position. The Chapter offers local life science companies a free job posting service to help them fill vacancies. Check out the " Jobs and Internships " section of the Chapter website and "like" the  Chapter's Facebook page  to receive notifications when new positions are posted. We have already reached our goal of posting 75 positions and we're adding more every week! Remember, you have to be an ISPE Member to access these positions.

Chapter Student Members attended a great plant tour at Shire on March 30. Students were treated to a presentation describing the activities that happen inside Shire's disposables facility which was followed by an informative tour of Shire's upstream and downstream processing operations. Students learned a tremendous amount about Shire's "first in class" disposables facility and operations and got an up-close look at some of the advantages and challenges of utilizing disposable technology.

Thanks to Shire for hosting a behind-the-scenes plant tour for the Chapter's Student Members.

The Chapter's outreach efforts continued this spring with participation at three on-campus Career Fairs at UNH, UMass Lowell and WPI. Chapter representatives met with faculty, students, career center staff and administrators to strengthen bonds and build new relationships while working to show students the benefits of belonging to an active professional network like ISPE.

This spring's Annual Poster Contest was held on Wednesday, April 20 at WPI's Biomanufacturing Education and Training Center in conjunction with the Chapter's April educational program. Students who did research and prepared a poster for one of their classes, had a chance to share their work, polish their presentation skills, compete for one of two $500 cash awards and meet a hundred or so local ISPE members who can open a door or two on the employment front!

Winning undergrad Connor Williams of UMass Lowell ("NIR-Based Absorption Photometer Enables Real Time Monitoring of Optical Density in Yeast Fermentation")

 

Winning grad student John De La Parra of Northeastern ("Controlled Biosynthesis and Diversification of Plant-Derived Pharmaceuticals")

And lastly, the  Chapter's Scholarship Program  wants to help you pay for the cost of your education. Twice a year, the Chapter awards $12,500 in scholarships as part of the Chapter's commitment to giving back and investing in you. The next application deadline is June 1. Applying is easy and your chances of receiving a scholarship are much higher than you might expect. You can  apply online here , but don't wait until the last minute. A written reference is one of the requirements and must be submitted online before the deadline, in addition to your completed application. If you miss the June deadline, don't despair - the next deadline is November 1.

If you need any further convincing of the benefits of being part of an active professional network, check this out:  https://vimeo.com/148636910 . And remember, students can attend the Chapter's educational programs and YP social events for free! Hope to see you on campus or at an ISPE event soon!

 

Congratulations to the Chapter's Annual Poster Competition Winners!

by Janet Tice, GMP Piping, with photos by Brian Hagopian, Clear Water Consulting

Congratulations to our 2016 Poster Competition winners!

• Connor Williams of UMass Lowell ("NIR-Based Absorption Photometer Enables Real Time Monitoring of Optical Density in Yeast Fermentation") in the undergraduate category

• John De La Parra of Northeastern ("Controlled Biosynthesis and Diversification of Plant-Derived Pharmaceuticals") in the graduate category

And kudos to James Carroll of Northeastern and Middlesex Community College, and Shannon Guertin and Elaheh Kamaloo, both of WPI, all of whom made the judges' job especially difficult this year.

The winners were each awarded $500 and expense-paid trips to the ISPE Annual Meeting in September where they will compete against winners from ISPE Chapters and Affiliates around the globe. Our Chapter has brought home the "gold" several times, most recently in 2015. Let's hope our track record continues for Connor and John in 2016!

Poster contest winner  Connor Williams of UMass Lowell ("NIR-Based Absorption Photometer Enables Real Time Monitoring of Optical Density in Yeast Fermentation") in the undergraduate category.

 

Poster contest winner John De La Parra of Northeastern ("Controlled Biosynthesis and Diversification of Plant-Derived Pharmaceuticals") in the graduate category.

As a Poster Competition judge for three years in a row, let me say it is truly a privilege to be introduced to several of the best and brightest among our Student Members, and listen to them describe their research and respond to tough questions with poise and professionalism. And beyond their poise and professionalism, there is even more - passion and enthusiasm for the work itself and for the opportunity to explain it to a new audience. It's an experience that always leaves me feeling good about the future of our industry and the positive role that our Chapter plays in that future.

Many thanks to this year's judges, Immediate Past President Chris Opolski, and former ISPE International Poster Competition winners Dawn Eriksen (2006) and Sydney Shaw (2015), both of whom were able to provide valuable insights based on their prior experience. And finally, thank you to Student Development Committee Co-Chairs Paige Kane and Brian Hagopian for continuing to nurture one of the Chapter's most enduring and gratifying traditions.

Page last updated: 5 May 2016