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Ski Outing Succeeds Despite Rocky Start

by Jim Grunwald, Commissioning Agents Inc, and Peter Fox, T&M Associates

The Boston Area Chapter celebrated its 15th Annual Ski Outing on March 6 with a trip to Waterville Valley where the skiing, riding and banquet were enjoyed by 65 attendees. The conditions were perfect for a great day on the mountain and the banquet was a fantastic networking event as well.

The group proved their resilience upon learning at the last minute that the bus had broken down and would not be available for the trip to Waterville! Within short order we made contingency plans and a number of people volunteered to drive to the mountain. The Chapter would like to thank all of the individuals who offered rides - you all really saved the day!

We look forward to the continued success of the Ski Outing and all of the Chapter’s social events, which we could not execute without the support of our many great sponsoring companies. We would like to acknowledge and thank our many sponsors for their support of the Ski Outing:

  • A/Z Corporation
  • Bard, Rao + Athanas Consulting Engineers
  • Commissioning Agents
  • GxP Automation
  • Perkins + Will
  • Superior Controls
  • T&M Associates
  • Ultrafiltronics

We hope you can join us for our next event, the Spring Golf Outing on May 11 at Ledgemont Country Club in Seekonk, MA. We look forward to seeing you there!


FDA and Industry Speakers Discuss Risk Assessment at March Educational Program

by Eric Felz, Shire, with photos by Joyce Chiu, Honeywell Safety Products

The Boston Area Chapter educational program entitled “Risky Business: How Quality Systems and Risk Blend” was held on Thursday, March 19 at Shire’s 200 Shire Way facility in Lexington. The event started with tour guides shepherding small groups through the chilly winter weather to the 400 Shire Way facility. Once at their destination, attendees were guided through Shire’s state-of-the-art facility where disposable bioreactors are used for cell culture operations. The tours took the better part of an hour and gave attendees a chance to ask questions about the facility and the processes taking place there. The tour guides proved to be great ambassadors for the facility, describing the operations and the disposable technology housed there with knowledge and enthusiasm.

 The topic of risk assessment and top-quality speakers combined to create a packed house
for the March educational program.

While one group toured, the other group mingled and met at the networking reception held at 200 Shire Way adjacent to Fortis Hall where the program would be held.  This was an opportunity for attendees to talk with the speaker outside of the confines of a regulatory inspection.  Following the reception, the evening began with opening remarks by Chapter President Chris Opolski and Program Manager Eric Felz who introduced the evening’s first speaker, Edmund Mrak, Drug Specialist, New England District of Food and Drug Administration and member of FDA’s Pharmaceutical Inspectorate.

Ed built an enlightening talk around risk assessments and how they fit into the overall quality structure.  He was able to keep a heavy subject light and a large and diverse audience fully engaged. His ability to weave together his own stories about his inspections and some of his own touch points with quotations from regulations allowed the audience to better understand how risk fits into the overall quality systems. There was a strong back and forth interaction between Ed and the audience. He seemed as interested in hearing questions from industry as we were in hearing what he had to say on the subject.

   FDA Inspector Edmund Mrak (center) chatted with attendees prior to his presentation.

At the conclusion of Ed’s presentation, Shire’s Xach Kibbie, Senior Risk Program Manager, Quality Risk Management Department, joined Ed on stage to give the industry’s perspective on the use of risk assessments and risk tools.  This point and counterpoint created a strong perspective on when and how to use these assessments to maintain compliance and allowed the audience to walk away with a strong understanding of risk management concepts.  Overall audience feedback was positive with many saying the event hit the correct tone and was both informative and interactive.

As always, food, drink and conversation were a perfect match at the networking reception.

The Boston Area Chapter and Program Managers Eric Felz, Mike Foshey, and Nagmeh Salimi would like to thank panelists Edmund Mrak and Xach Kibbie for their uniquely valuable insights, the tour guides for their knowledge and enthusiasm and Shire for providing a comfortable venue for the event and inviting us into their manufacturing facility. And last but not least, RCM Technologies for their generous sponsorship of this event.


April Educational Program Features Student Poster Competition

by Dan Mardirosian, Worcester Polytechnic Institute, and Christopher Ciampa, Thermo Fisher Scientific, with photos by Joyce Chiu, Honeywell Safety Products, and Karima Erriahi, UMass Lowell

“Downstream Processing, How It's Done and How To Do It Faster & Better” was held on Thursday, April 16 at Worcester Polytechnic Institute’s Gateway Park in Worcester. This was a dual-track program featuring both introductory and advanced presentations on the topic of downstream processing. In addition, the 2015 Student Poster Competition was held during the networking reception with the winners announced prior to the presentations.

Dual track educational programs offer something for everyone: students, young professionals and industry veterans.

The turnout was a healthy 70-plus, with two-thirds of the attendees choosing the introductory track at the Biomanufacturing Education & training Center (BETC) and the rest visiting the Life Science and Bioengineering Center (LSBC) next door for the advanced track. The advanced track was recorded by the Chapter for future presentation at the Crowne Plaza Hotel in Warwick, RI for Members from areas to the south, while the introductory track was recorded by WPI using their Echo system. If the latter recording can be edited and uploaded, this track will also be available for future use by the Chapter.

The networking reception, featuring a delicious pasta and salad bar, was well attended and provided an opportunity for viewing the posters and discussing them with the students who also made individual presentations before a panel of judges tasked with determining the winners. Tours of the BETC were also available. Opened in 2013, the BETC is a 10,000 sq.ft. facility outfitted with bench to pilot scale biomanufacturing equipment. It is dedicated to providing corporate and professional educational programs that respond to the needs of the biomanufacturing industry's workforce development efforts.
Following the networking reception, the evening began with opening remarks by Chapter President Chris Opolski and Program Manager Dan Mardirosian. Chapter Past President Brian Hagopian then announced the winners of the Student Poster Competition. Congratulations to graduate winner Sydney Shaw from Northeastern University and undergraduate winner D. Ezra Aurian-Blajeni from UMass Amherst. Both winners received $500 awards and will be travelling to the ISPE Annual Meeting in November at the Chapter’s expense to compete at the international level.

   Congratulations to Poster Competition winners undergraduate D. Ezra Aurian-Blajeni (l) from UMass Amherst and grad student Sydney Shaw (r) from Northeastern.

Following the announcements, the group separated and attended their session of choice. The advanced session was presented by Dr. Kathleen Mihlbachler, Global Director of Separations Development, LEWA Process Technologies. The downstream process (DSP) has become the "bottleneck" in the manufacturing of bio-pharmaceuticals, especially monoclonal antibodies. Dr. Mihlbachler’s talk, “Integrated Continuous Downstream Processing - An Enabling Approach that will Break the Bottleneck,” was designed for seasoned professionals interested in the newest DSP technologies with which to address the ever-increasing production and efficiency of the upstream process.
Different integrated downstream processes and/or multi-column continuous chromatographic technologies have been investigated that showed promising results in reducing manufacturing costs. However, until today there has not been a reported case at the production scale. Dr. Milbachler discussed the utility of continuous chromatography and discussed in detail simulated moving bed (SMB) technology and multi-column continuous purification (MCC). She also discussed the remaining barriers to implementation and how to overcome them in the GMP environment. The presentation was very interesting and sparked a number of questions.

   WPI’s Dan Mardirosian introduced Dr. Kathleen Mihlbachler whose presentation was designed for seasoned professionals interested in the latest DSP technologies.

Meanwhile, Kamal Rashid, Ph.D, Director of the BETC, introduced Stuart Green, VP of Process Engineering for Pall Corporation's Life Science Division of North America. Stuart’s presentation, “Downstream Processing Techniques and Single Use Applications,” introduced the unit operations typically carried out to purify a cell culture product.  Participants gained an understanding of what the contaminants are and how they can be removed - the first step in understanding how the downstream process should be designed – and how virus inactivation and removal, chromatography and UF/DF are achieved and best arranged in a process.
He also described the evolution of the technology: in the 1990s, plants were running the process using stainless steel and the process took about a week from start to completion.  Today, the technology has changed to disposable single use and the process time is half a week!  In addition, the merits of single use options for downstream processing were discussed. The questions were numerous with the best one regarding pain points in the downstream process. According to the presenter, proper cleaning is the biggest concern. If there are contaminants in the process, it could cost the plant millions in lost product!

   Attendees at the introductory presentation were treated to a surprise tour of the Biomanufacturing Education & Training Center led by BETC Director Dr. Kamal Rashid.

In summary, a great deal of information was shared dfuring the evening by two highly knowledgeable presenters with many years of industry experience. 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 Student Poster Competition was the icing on the cake! Congratulations again to the winners!

The Boston Area Chapter and Program Managers Dan Mardirosian and Chris Ciampa would like to thank the presenters, organizers and audience members for their valuable contributions to this program and to WPI for providing the venue and support staff for the event. Great Job!


Student Development Update

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

Student Chapters Just Keep Growing!

The Boston Area Chapter continues its blitz on university campuses again this year, reaching a new high of 11 Student Chapters with a few more in the process of forming.  We’ve also reached new highs in student membership with over 270 Student Members, the most student members of any ISPE Chapter!  The graph below provides a breakdown of student membership by Student Chapter from August 2014 through March 2015.


There was a major increase in student membership at Mass Maritime Academy immediately following the October Product Show. Student membership has increased consistently at Northeastern, University of New Hampshire, UMass Amherst, and Middlesex Community College throughout the school year, which is a testament to the strong efforts of students and faculty on these campuses.

Student Poster Competition a Huge Success! 

This year’s Student Poster Competition was held on April 16 at WPI’s BETC concurrently with the Chapter’s April dual-track educational program.  We had a record number of entries this year in the undergraduate and graduate categories.  Coupling the Poster Competition with the educational program gave students the opportunity to interact with the many industry professionals who attended the program – a definite plus for both contestants and attendees. The competition was stiff and the graduate category was a “dogfight” but the Chapter is proud to announce the following winners:

  • D. Ezra Aurian-Blajeni, UMass Amherst: “Droplet-Interface Bilayers: An Emerging Technology for Screening Human Ion Channel-Drug Interactions” (undergraduate category)
  • Graduate:  Sydney Shaw, Northeastern: “The Effect of Light, Jasmonate and Tissue Organization on the Expression of Vindoline Greens in   Catharanthus Roseus  ” (graduate category)

Each winner receives a $500 cash prize and an expense-paid trip to compete in the International Poster Contest at ISPE’s Annual Meeting in Philadelphia in November. Congratulations Sydney and Ezra!

Scholarship Application Deadline June 1

The Boston Area Chapter awards up to $25,000 in scholarships annually to qualifying ISPE Members.  The Chapter has a track record of awarding scholarships to about 50 percent of applicants - where else can you find such a high chance for success? Beginning with this round, applications and written references are completed online – no more paper! So be sure to visit the Chapter website at   www.ISPEBoston.org/scholarships/    and complete your application by June 1.

Life Sciences Panel Discussion at UMass Lowell

This exciting program attracted over 50 students interested in the life sciences industry.  Panelists spoke of the importance of networks and Chapter Members had the chance to share information about ISPE with a number of interested students.  Northeastern’s Graduate Women in Science and Engineering held a resume review session attended by Suzanne Stuhler and Brian Hagopian, who advised students on building a strong resume as they prepare to enter the job market.

Remember, Student Members Attend ISPE Educational Events For Free

Remember, once you join ISPE as a Student Member (  www.ispe.org/join-or-renew  ), you can attend all Chapter educational and related events for free!  Membership in the Boston Area Chapter truly does have its privileges!

Page last updated: 8 July 2015