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Continuous Manufacturing Educational Program Breaks Attendance Records

by Brian Hagopian, Clear Water Consulting, with photos by Joyce Chiu, Honeywell Safety Products

The January educational program at Biogen Idec gave us a glimpse into the future of manufacturing with a focus on advances in continuous manufacturing.  With the local biotech industry primarily locked into batch processes, three speakers presented information on how some products are being made continuously RIGHT NOW!  And Chapter Members turned out in droves to learn how and why. After hearing from all three speakers, it became abundantly clear that adapting a process to continuous manufacturing is highly beneficial because continuous manufacturing reduces capital requirements, minimizes footprint and allows for the continuous production of products.

Chapter Past President Dave Novak greeted attendees during the networking reception.

Salvatore Mascia, Ph.D. of Continuus Pharmaceuticals discussed the use of an integrated continuous manufacturing (ICM) process developed through collaboration between MIT and the Novartis Center for Continuous Manufacturing for the production of small molecules.  Adapting a process to continuous manufacturing poses some challenges and may require “outside the box” thinking.  Dr. Mascia described how several batch processes were analyzed for capacity and throughput and then how each step was synchronized to allow for a clean flow from one step to the next.  This allowed each modular process to be linked to others.  The net result is that an identical quantity of material can be produced continuously with less capital while requiring a smaller footprint.

The evening's cutting edge topic drew a large crowd to Biogen Idec for the Chapter's January educational program.

Maurizio Cattaneo, Ph.D, CPIP of BioVolutions described how Quality by Design (QbD) and Risk Assessment tools were used to determine critical process parameters (CPP’s), which then allowed the application of continuous manufacturing principles to the production of monoclonal antibodies (mAbs).  In the case of mAbs, a batch cell culture process was adapted to a perfusion process, which allows for continuous harvesting at a much earlier stage in the game.  He then described how a continuous harvest was synchronized with a chromatographic purification process where “mini-batches” of mAbs were applied to a column, eluted, and more material was applied multiple times within the same column.  After purification, the “mini-batches” were tested, pooled, and sent to the fill/finish step.  Dr. Cattaneo described this process as producing higher quality product on a continuous basis using fewer steps, requiring less capital and significantly less space, and producing product in about two-thirds the time of conventional batch processes.

Kathleen Mihlbachler, Ph.D. of LEWA Process Technologies described recent advances in Multi-Column Continuous (MCC) Chromatography and Simulated Moving Bed (SMB) Chromatography for the separation of products from their impurities as well as separating mirror image compounds (chiral molecules) from each other.  Dr. Mihlbachler described a continuous separation process for small molecules where several columns were used simultaneously in a defined sequence to separate product from impurities.  While this technology has been used to separate small molecule chemicals and low molecular weight food products, she showed an example of how chromatography could be adapted to continuously separate biomolecules.  Dr. Mihlbachler closed with a brief discussion of the regulatory challenges of transitioning from batch to continuous manufacturing.  Dr. Mihlbachler will be speaking on a related topic at the Chapter’s April 16 educational program being held at the Worcester Polytechnic Institute Biomanufacturing Education and Training Center at Gateway Park in Worcester.

Presenters (l to r) Salvatore Mascia, Maurizio Cattaneo & Kathleen Mihlbachler joined forces to explain the hows & whys of continuous manufacturing.

There was a lively question and answer period after each presentation had been completed followed by many one-on-one discussions after the session ended, a clear indication of the high interest level in continuous manufacturing. Many thanks to Biogen Idec for providing the venue for this thought-provoking program. 


ISPE and I²SL Join Forces for Networking and Fund Raising at Flat Top Johnny’s

by Aarash Navabi, CPIP Genzyme, a Sanofi Company, with photos by Joyce Chiu, CPIP Honeywell Safety Products

On January 21 the Chapter held its first networking event of 2015 - our traditional Holiday Social at Flat Top Johnny's in Kendall Square. Adding a new twist to this annual event, this year we partnered with I²SL (International Institute for Sustainable Laboratories) and were more than pleased with the outcome. With almost 130 people in attendance and a variety of mouthwatering appetizers, unlimited pool tables and an array of local brews to sip on with friends, old or new, the event was one of ISPE's most rewarding social events ever.

This year I2SL joined the Boston Area Chapter at the Holiday Social and helped raise funds for the ALS Foundation.  

In addition to the food, drink and networking, the event was also a benefit for the ALS Foundation. ALS, also known as Lou Gehrig's disease, is a progressive and ultimately fatal neurodegenerative disease, one that deserves attention and support year-round. Not long ago the Foundation was the center of attention as people raised awareness by participating in the ALS Ice Bucket Challenge. Due to the excellent turnout and the generosity of our guests, we did our part by raising over $1000 for this worthy cause in just one night.


The pool tables are always a big attraction
at Flat Top Johnny's.

A very special thank you to all who bought raffle tickets and to the generous organizations that made our success possible by donating an array of fantastic prizes:

  • Commissioning Agents - $125 Gift Card to Catalyst 
  • Digital Dynamics - Chromecast
  • GxP Automation - Glenlivet 15-Year Single Malt Scotch
  • L.J. Star - Digital camera 
  • Perkins + Will - Two Red Sox tickets
  • RW Sullivan - Round of golf at Kernwood Country Club
  • Sentrol - $100 Gift Card to Row 34 
  • The Richmond Group - $100 Gift Card to Legal Seafoods

Following the Holiday Social the Chapter has an outstanding schedule of social and recreational events planned for 2015, with the Annual Ski Trip next up on March 6 and the Spring Golf Outing not far behind on May 11. If you've never attended one of these events, make this your year to join in the fun. And if you've been before we know we'll see you this year, too!


Career Workshop Draws 50 Student Members to Northeastern

by Jen Duffy, Shire, with photos by Brian Hagopian, Clear Water Consulting

Another highly successful Student Career Workshop took place on February 7 in the Alumni Center at Northeastern University. Despite the weather, over 50 students attended the event from places as far away as Maryland and Missouri, making this the largest Career Workshop yet.  Last year students left the workshop with great advice and returned this year with friends and classmates eager for the opportunity to learn from industry professionals. With the interactive and encompassing agenda, it is easy to understand why this event keeps growing.

The daylong workshop covered everything a student needs to know to increase their chances of getting the internship, co-op or full time position they are looking for in the life sciences industry. The workshop kicked off with a presentation on the value of networking.  Presenters next took students out of their “comfort zone” with an interactive exercise during which students practiced their networking skills to prepare them for their first introductions to professionals they are sure to meet.

Next, starting at the beginning of the career path, an approach to self-analysis was discussed, enabling students to recognize the strengths they have to offer and explaining how to incorporate these positives into effective resumes and cover letters. Students began working their way through a series of carefully created worksheets to help guide them through each topic of the day from first impressions and interviewing tips, to creating goals using the SMART planning tool (specific, measureable, attainable, relevant and time bound) for long term career path planning. 


Students listened intently as Chapter Member Katie Shannon described how
she landed her dream job at Biogen Idec.

Other sessions provided students with abundant insight on what employers are looking for and why networking is important. Students also had the opportunity to network with professionals and ask the questions important to them in a one-on-one setting.  With questions ranging from the general “What are the roles and responsibilities of different groups in the life sciences industry?” to specific questions on the most practical path to reach particular goals, there was something for every student to learn from the speakers and from the other students as well.

A particularly engaging portion of the workshop for both students and professionals was the chance to hear how successful professionals got to where they are today. These stories shared an individual’s life experiences, how they made career decisions and the lessons they learned along the way. Attendees were also able to choose from three outstanding books specifically written for graduates seeking jobs to take home with them, providing further help with the job search and interview process. 
This annual event is a fantastic opportunity for students to “learn from the best” and for professionals to give back and help shape the future of the life sciences industry. It’s a great feeling to be able to remember what it’s like to be entering the “real world” for the first time and all the questions that go along with that, and to be able to make a positive difference in the lives of students who are looking ahead to graduation and becoming part of the life science industry. 


These Fun and Educational Young Professional Events Are Sure to Cheer You Up!

by Chris Ciampa, Thermo Fisher Scientific, and Lucas Wafer, Pfizer, with photo by Dave Gallagher, GxP Automation

What was shaping up to be a snowless winter has turned into a nightmare for the New England area.  How quickly things can change, as December was a very mild, dry month!  The total accumulation of snow this winter is 78.5 inches. It is doubtful that spring is only a few weeks away.  An arrest warrant is currently being issued to Punxsutawney Phil, who believes that he saw his shadow!  Have no fear - even as the weather worsens, we have some great YP events for you to look forward to!

On Wednesday, February 25 the YPs were back at Medieval Manor.  If you are looking to experience life as it was in the dark ages, we hope you were there! Where else would you have the opportunity to enjoy food from medieval times "hands on" style without using a fork, knife, or spoon? Back by popular demand, this event also allowed YP members to network and mingle with the Chapter’s seasoned industry experts.


Medieval fun not your thing?  Perhaps you are more interested in bowling and pizza. In April, the YPs are heading to Davis Square to Flatbread/Sacco's.  There is no date set but we are looking at the week of April 27.  This will be a fun night of networking, all-you-can-eat pizza and salad, and local craft beers.  Not only that, but Sacco's also offers its famous candlepin bowling and Flatbread makes delicious, organic, wood-fired pizza.  As a combined company, Flatbread and Sacco's Bowling has been a staple in the Somerville community for over 60 years.   

With the success of Night Shift Brewery in December, a plan is in place to host another brewery tour at Aeronaut Brewery in Somerville in the near future.  This presents another opportunity for the Chapter Members to learn more about the beer-making process.

Switching gears to the educational perspective, there are a couple of events designed to familiarize YP engineers with current issues and trends.  On Thursday, April 16 a dual-track educational program will take place at WPI.  The YP portion of the event will cover “Downstream Processing Techniques and Single Use Applications” at the introductory level and will focus on purifying cell culture and ensuring that a downstream process is contaminant free.  The speaker is Stuart Green, VP of Process Engineering for Pall Corporation’s Life Science Division in North America. Plan to arrive early for the Chapter’s Annual Student Poster Competition being held in conjunction with the dual-track program and lend your support to the students (and future YPs) displaying their research. Winners receive $500 and a chance to attend the ISPE Annual Meeting and compete at the international level. Keep an eye out for a Chapter email with all the details.

Other future educational events are currently in the planning stage.  One of the prospective events involves automation, which is a common theme for many engineers across our industry. Nothing has been set in stone yet but we could do a lecture on automation and/or a seminar on improving automation.  We are also looking into the possibility of having education events in the near future on two pertinent industry topics: relevant industry standards (USP, CFR, ISO, ASTM, etc) and the impact of commercial operation on regulatory filings.

As always the YPs would love to hear from you. If you have ideas for social or educational events or wish to attend a committee meeting, please feel free to contact Jared Marshall at jared.marshall@genzyme.com  or Christopher Ciampa at  christopher.ciampa@gmail.com . Also, if you are new to the industry and looking to get some exposure on an international level, there is an opportunity to get your name out on the ISPEAK blog.  Please feel free to reach out to Jared if you would like more information on this.

Thank you for tuning in and stay warm, safe, and healthy as the winter season progresses!


Page last updated: 6 May 2015