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UMass Crown Jewel Shines at April Educational Program

by Joyce Chiu, Honeywell Safety Products; Paul Doherty, CRB Builders; Doyle Johnson, Hargrove Life Sciences; Mike Severino, Festo; with photos by Joyce Chiu and Mark J. Jodoin, Symbotic

With the coming signs of spring it was fitting that the April Educational program entitled “Facility Optimization and Process Improvement” was combined with a facility tour of the brand new Massachusetts Accelerator For Bio-Manufacturing (MAB) at UMass Dartmouth (UMD).  This program enabled the university to unveil its latest life sciences asset with facility tours and a follow-on presentation from the design, engineering, construction, university and industry team that had the vision, concept and experience of building this life sciences gem.

The UMass Dartmouth Massachusetts Accelerator for 
Bio-Manufacturing (MAB) was both venue and topic
for the April program.
   

The uniqueness of this program and venue attracted a near-capacity crowd to the MAB. In addition to those lucky enough to attend the program in person, a second group of attendees  participated via video simulcast at the Emerging Technologies and Innovation Center at UMass Lowell. The Chapter is piloting this use of technology as part of its Geographic Outreach (GO) initiative designed to bring educational programs to Chapter Members throughout New England.

First on the evening’s agenda was an information-packed facility tour. Tour guides brought their own perspective on the facility and its construction challenges, while location-critical experts presented details and interacted with attendees at each stop. During the tour, attendees in Lowell were treated to a previously-recorded video tour of the facility. Following the tour, attendees at both locations were welcomed by a full hot/cold buffet and drinks and were free to mingle and network with their peers prior to the presentations.

 

Tour guides brought their own unique perspective on the MAB and
its construction challenges.
     

The MAB

The Massachusetts Accelerator for Bio-Manufacturing (MAB) is a 27,745 sqft facility located at the SouthCoast Life Sciences and Technology Park, in Fall River, MA.  According to a press release issued by the governor’s office following the groundbreaking in 2012, the MAB is “the only facility in the U.S. where startups will be able to test their biomanufacturing methods and bioproducts at every stage of development and access full-service support from business and marketing to pure science support – all under one roof.” 
 
The heart of the facility is designed around four flexible suites complete with the necessary support services required for production, pre-production and research activities. The facility will serve client companies with traditional biologic therapeutic products, new types of products using stem cells and tissue engineering, as well as biomaterials, biofuels and green chemistry products.  The “GMP like” manufacturing area includes:

• mammalian cell culture and purification capability up to 300L scale;
• microbial fermentation and purification capability up to 300L scale;
• stainless steel and single use cell culture fermenters; 
• flexible services including QA/environmental monitoring, full utilities (RO/DI water, clean steam & gases), waste stream management, data collection, media and column prep and secure access; and quarantine and release storage areas.

In addition to the complete production services, the facility has a QA/QC, R&D and training labs, lecture halls and office suites. 

The Program

The Program As the sun set so did the networking session and at approximately 6:30pm everyone was asked to take a seat in the lecture hall for the program portion of the evening. An energized Michael Levesque of the Chapter’s Educational Program Committee provided opening remarks and introduced Mark Trusheim, President of Co-Bio Consulting and Bio-manufacturing Executive in Residence at UMass Dartmouth.

Behind-the-scenes facility tours are one of the Chapter's most
popular member benefits.

Mark led off the program from the perspective of someone who had been involved in the development of the MAB since it was merely a gleam in legislators’ eyes. Mark’s first slide showed that New England has more liters of biomanufacturing volume than California, New Jersey, South Korea or any other country in the world. The MAB is then a logical extension of that biotech pre-eminence and New England should just get bigger and better!

Chris Brigham of UMass Dartmouth described the opportunities for learning that the MAB will provide to UMD undergraduate and graduate students. Instead of merely discussing and reading about fermentation, downstream purification and QC, students will have the chance to experience these concepts in a hands-on, real-world environment with some of the experts in the industry.

Sharon Jozokos of Suffolk Construction explained her role in project budgeting, planning and value engineering. There were many changes as this project was built and Sharon and her team had to analyze each for effects on cost and schedule. What made this especially challenging was the need to follow state procurement rules such as 149A, which applies when bids exceed the budgeted amount. Suffolk also made good use of the BIM model to construct the interstitial space, which became extremely crowded when a late design change required production spaces to operate more independently, something that was apparent on the tour earlier in the evening.

The evening's speakers with UMass Dartmouth Student
Chapter Members.

Nate Hafer of UMass Medical spoke next as a last-minute substitute for MAB President Paul Vigeant of UMass Dartmouth. The mission of the MAB is to provide training (at both the advanced graduate level and entry level for undergraduates), university-industry partnerships in applied research and building a statewide network linking the UMass system and private colleges and universities. The MAB board of directors, with representatives from the university system and industry, hopes to eventually have 15-20 clients per year for engineering scale-up, proof of production concept and product demonstrations.

Steve Fitzpatrick of DPS Biometics wrapped up the evening with a presentation on the design of the MAB. Architecturally the building was intended to mimic the shape of an enzyme-substrate complex. The facility is capable of up to 300L stainless steel microbial fermentation and up to 250L single use mammalian cell culture, with dedicated HVAC for each. Each production suite is “equipment agnostic,” designed as plug-and-play so that almost any brand or type of equipment can be used in any configuration. This was an essential feature in the MAB’s role as a demonstration facility for a wide variety of current and future process technologies.

Thank You

On behalf of the Boston Area Chapter, the Program Managers would like to thank UMass Dartmouth and the entire state university system for opening their doors and unveiling the next life sciences training and collaboration facility for the New England region. The MAB will help ensure that Massachusetts maintains its unique position as one of the most influential life sciences clusters in the world. 

We would also like to thank the many volunteers at the MAB for making the tours fun, engaging and memorable; and each of the presenters for their insight, knowledge and life sciences expertise and for making this a benchmark evening for the new crown jewel of the UMass life sciences facility portfolio.

And lastly we would like to thank our programs sponsor, CRB and Festo, whose support enables the Boston Area Chapter to provide high-quality educational programs such as this.  

Saying Goodbye to Winter at the Spring Golf Outing

by Dan Kenny, Northeast Engineering

The ISPE Boston Area Chapter hosted the First Annual Spring Golf Tournament on April 28 and Mother Nature was happy to cooperate. With the snow finally gone and the sun shining bright, ISPE Members and guests from all over New England put their busy schedules aside to join in a fun-filled day of golf and networking at Ledgemont Country Club in Seekonk, MA. The course was in excellent condition and the staff could not have been more accommodating.

Chapter Members and guests enjoyed gorgeous April weather at the
Spring Golf Outing at the Ledgemont Country Club in Seekonk, MA

 

 

Charged with scheduling the first golf tournament of the year, the Social Committee did not disappoint. The day started with a hearty lunch buffet, with a spread that had something for everyone, and no one went out on the course hungry. Once everyone was out on the course, the laughs and cheers were heard between Hole 1 and Hole 18 all day long. Once groups started funneling back to the clubhouse, the stories got funnier and the shots got better over a beverage at the fire pit, which was set up just outside the clubhouse. After some more stories, the last groups made it to the clubhouse and a dinner buffet got underway with a full carving station and all the trimmings, followed by an awards ceremony. Awards were handed out for first, second and third longest drive and closest-to-the-pin.

Congratulations go to our winning foursomes and our six individual winners:

 

First Place (67*)

Second Place (67*)

Third Place (67*)

Hart Design Group

BOND

Margulies Perruzi Architects

David Destefano

Shawn Donovan

Dan Madra

Andre Gill

Wayne Arruda

Rick Fisher

Steve Anderson

Bill Angelosanto

Dan Wall

Ed Sheridan

Lenny McAlister

Bill Mack

 

 

Women

 

Men

Straightest Drive

---

Jacob Hillman

Closest to Pin (tie)

---

Andrew Feibelman
Jason Fantini

Longest Drive

Antonella Cordella

Andrew Feibelman 

* Broke tie by back nine total 

In addition there was a 50/50 raffle to raise money for Heading Home, a non-profit providing emergency, transitional and permanent housing and support services to low-income families in the Boston area ( www.headinghomeinc.org ). All in all, a great day was had by all!

The Social Committee would like to thank everyone who attended the Spring Golf Tournament with a special thank you to the sponsors who played such a vital role in making this great day possible: Crosspoint Engineering, Northeast Engineering, RW Sullivan Engineering, Superior Controls and Thompson Consultants. We couldn’t have done it without you!

Hope to see everyone at the Chapter’s upcoming social and recreational events including the Summer Social on July 23 at Pier 6 in Charlestown and the Summer Golf Tournament on August 18 at Kernwood Country Club in Salem.

May Educational Program Heads West to Worcester

by Dan Mardirosian, Worcester Polytechnic Institute with photos by Joyce Chiu, Honeywell Safety Products

The ISPE Boston Area Chapter educational program entitled “Upstream Processing: Development and Optimization – Join Us and See Where It All Begins” was held on Thursday, May 17 at Worcester Polytechnic Institute at Gateway Park in Worcester. This was a dual-track program featuring introductory and advanced lectures related to upstream bioprocessing. There were approximately 55 attendees, both Chapter Members and non-members, with about half in each session.

The introductory track was beamed live to the Crowne Plaza Hotel in Warwick, RI for the benefit of a small group of GO (Geographic Outreach) Committee members and their guests. This was one of the final test runs for the GO Committee as they work towards their goal of simulcasting all education events to make them more accessible to Chapter Members throughout the New England region.

Speaker Kamal Rashid, Director of the Biomanufacturing & Training
Center at WPI, talks with a student following the advanced track
presentation.

The networking reception in Worcester featured a delicious pasta and salad bar and was well attended. During the networking reception, attendees at the live event were able to tour the new Biomanufacturing Education and Training Center (the BETC) which opened in 2013. The BETC is a 10,000 sq. ft. facility outfitted with bench to pilot scale biomanufacturing equipment dedicated to providing corporate and professional educational programs to respond to the needs of the biomanufacturing industry's workforce development efforts.

The evening began with opening remarks by Boston Area Chapter Past President Brian Hagopian, ISPE Board Member Jack Campion and Program Manager Dan Mardirosian. The introductory session was held at WPI’s Life Science and Bioengineering center and was presented by Norman Garceau, PhD, Chief Scientific Officer, Blue Sky BioServices; William Hermans, Head of Cell Culture and Scale Up, Blue Sky BioServices; and Scott Gridley, PhD, Vice President of Business Development, Blue Sky BioServices.

Dr. Garceau began with an overview of microbial expression systems focusing on E.coli, E. coli expression vectors and an overview of the microbial fermentation process. William Hermans then presented an introduction to insect cell culture and the baculovirus expression system and its applications. The introductory track was completed by Scott Gridley who presented an introduction to mammalian cell culture systems and processing. The various cell types and expression systems were discussed, compared and contrasted, providing the applications and benefits of each.

Meanwhile, at the BETC, Kamal Rashid, Ph.D, Director of the BETC presented the advanced track on upstream manufacturing which covered cell line development, media optimization and scale-up strategies.

In summary, a great deal of information was shared during the evening by four highly knowledgeable presenters. A number of questions and comments from the audience followed to fill in the few gaps that remained. The evening’s program as a whole was a success, delivering quality information on a topic of significant interest and relevance to Chapter Members.

The Boston Area Chapter and Program Manager Dan Mardirosian would like to thank the presenters, organizers and audience members for their valuable contributions to this program and WPI for providing the venue for the event.

Panelists from Baxter, Genzyme & Shire Wow Audience at June C&Q Program

by Rob Beane, Barry-Wehmiller Design Group, with photos by Mark J. Jodoin, Symbotic LLC and Joyce Chiu, Honeywell Safety Products

The Boston Area Chapter conducted an educational program on June 19 at Tufts Gordon Institute in Medford consisting of a presentation and associated Q&A panel focusing on the various ways different life sciences companies employ risk- and science-based tools and techniques for Commissioning and Qualification.

Program Manager Rob Beane (r) with (l to r) panelists Stephen Kuzil,  
Michelle Whipple and Eric Felz and speaker Geoffrey Von Holten.

With the industry driven to ensure that the focus of compliance activities is on those elements that have the most impact on the quality, safety and integrity of their products, the speaker and panel members were selected from a variety of life science leaders to provide different perspectives on the topic and a broad spectrum of real world examples of the programs they employ.

In addition to the live program at Tufts, the event was also simulcast remotely to the Crowne Plaza Hotel in Warwick, RI for the benefit of the Chapter’s GO (Geographic Outreach) Committee members and their guests. This was one of the final test runs by the GO Committee as they work toward their goal of making all educational programs accessible to Chapter Members throughout New England via simulcast.

In a final test run, the Chapter's GO Committee attended the June
program in Warwick, RI via simulcast.

Following the traditional networking reception, the evening began with opening remarks by Boston Area Chapter Past President Brian Hagopian, Tufts Gordon Institute Associate Director Nancy Buczko and Program Manager Rob Beane. Geoffrey von Holten, Principal at GvH Consulting, followed with a presentation entitled “Risk Based C&Q:  What’s Everyone Else Doing?” during which he provided an overview of the relevant risk assessment guidance documents: 

    • ISPE Baseline Guide 5, 
    • ICH Q8 – Pharmaceutical Development, 
    • ICH Q9 – Quality Risk Management, 
    • ICH Q10 – Pharmaceutical Quality System, 
    • ASTM E2500 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment and 
    • ISPE Guidance Document - Science and Risk-Based Approach to Delivery of Facilities, Systems and Equipment.  

Geoff also presented his experiences using three case-studies from projects executed using three very different compliance approaches.

Following Geoff’s presentation, the program switched gears and welcomed panelists Eric Felz, Associate Director of Validation, Shire; Steve Kuzil, Associate Director Commissioning and Qualification, Genzyme; and Michelle Whipple, Senior Manager, Validation, Baxter who fielded questions posed by audience members at both locations. The many insightful questions included definition and assignment of SMEs, transition of quality systems during commercial operations and management of vendors to get the most out of FAT/SAT efforts.

The Boston Area Chapter and Program Manager Rob Beane would like to thank Geoffrey von Holten for his very informative presentation, the panel members for their insightful responses to the audience questions and to Tufts Gordon Institute for hosting the Chapter at their Medford facility.

Page last updated: 9 July 2014