2011 Biomanufacturing Summit Details

MIT Center for Biomedical Innovation’s Biomanufacturing Summit
Implementing Innovation in Biomanufacturing: The Hurdles and Opportunities

November 18, 2011 (8:30 AM – 6:30 PM)

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Event Details:

Date: November 18th, 2011
Location: Bartos Theater (map)
Time: 8:30 AM – 6:30 PM (registration starts at 8:00 AM)
Morning Session: 8:30 AM – 12:15 PM
Afternoon Session: 1:30 PM – 5:15 PM
Poster and Networking Sessions: 12:15 PM – 1:30PM and 5:15 PM – 6:30 PM (Bartos Lobby)

This all-day event, featuring panel discussions and presentations by MIT faculty, members of the biomanufacturing industry and the FDA will examine how new science and engineering can reduce the barriers to regulatory approval of biotherapeutic drugs. Secondly, this Summit will explore potential opportunities for innovation in the production of antibodies, biosimilars, and therapeutic proteins. The day will also feature networking poster sessions during lunch and in the evening highlighting innovative research related to biomanufacturing at MIT.

Registration:

Attendance for MIT Faculty, Staff, and Students, as well as BioMAN members is free. For all other participants, the registration fee is $100 before November 8th and $150 thereafter.

Participants include:

  • Brian W. Anthony, Director, Master of Engineering in Manufacturing Program, Laboratory for Manufacturing Productivity, MIT
  • Jeffrey Baker, Deputy Director, Office of Biotechnology Products, FDA
  • Richard Braatz, Edwin R. Gilliland Professor of Chemical Engineering, MIT
  • Oliver de Weck, Associate Professor of Aeronautics and Astronautics and Engineering Systems, MIT; Executive Director, MIT Production in the Innovation Economy (PIE) Study; Co-Director, Center for Complex Engineering Systems at KACST and MIT
  • Anthony DiLeo, Director of Corporate Technology, Millipore Corporation
  • William Flanagan, Leader, Ecoassessment Center of Excellence, GE Global Research
  • Ajaz Hussain, Vice President NGP Assessment, Phillip Morris International
  • Beth Junker, Sr. Scientific Director, Bioprocess Development, Merck
  • Konstantin Konstantinov, VP Commercial Process Development, Genzyme Corporation
  • J. Christopher Love, Latham Family Career Development Professor of Chemical Engineering, MIT
  • Matthew D. Pietrzykowski, Lead Scientist, Ecoassessment Center of Excellence, GE Global Research
  • Thomas Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.; Consultant, Tarpon Biosystems
  • Anthony J. Sinskey, Faculty Director, MIT Center for Biomedical Innovation; Professor of Biology, Harvard-MIT Health Sciences & Technology, and Engineering Systems, MIT
  • Michael S.Strano, Charles and Hilda Roddey Associate Professor of Chemical Engineering, MIT
  • Bernhardt Trout, Professor of Chemical Engineering; Director, Novartis-MIT Center for Continuous Manufacturing, MIT
  • Ganesh Venkataraman, Founder and Senior Vice President, Research, Momenta
  • Morning Panel Discussion moderated by G.K. Raju, Chairman, BioMAN Steering Committee; Executive Director, Pharmaceutical Manufacturing Initiatives, MIT-CBI
  • Afternoon Panel Discussion moderated by Charles Cooney, Robert T. Haslam Professor of Chemical Engineering, MIT

 

Agenda:

Friday, November 18th, 2011
Registration (8:00 AM – 8:30 AM)
Welcome and Introduction (8:30 AM – 8:45 AM)
Anthony J. Sinskey
Faculty Director, MIT Center for Biomedical Innovation; Professor of Biology, Harvard-MIT Health Sciences & Technology, and Engineering Systems, MIT
Panel Discussion (8:45 AM – 10:00 AM)

Regulatory Science: What does it mean for Biomanufacturing?
Regulatory science is an applied science focused on developing new tools, standards and approaches to assess safety, efficacy and quality. There has been an increased focus on regulatory science across government (NIH, FDA), academia and industry in recent years. So what does it mean for biomanufacturing? This session will attempt to answer this question through a panel discussion among experts.

Panelists Include:
Dr. Jeffrey Baker
, Deputy Director, Office of Biotechnology Products, FDA
Professor Richard Braatz, Edwin R. Gilliland Professor of Chemical Engineering, MIT
Dr. Ajaz Hussain, Vice President NGP Assessment, Philip Morris International; (Former) Deputy Director, Office of Pharmaceutical Science, CDER at FDA
Dr. Beth Junker, Sr. Scientific Director, Bioprocess Development, Merck
Professor J. Christopher Love, Latham Family Career Development Professor of Chemical Engineering, MIT
Dr. Ganesh Venkataraman, Founder and Senior Vice President, Research, Momenta

Moderated by G.K. Raju, Chairman, BioMAN Steering Committee, Executive Director, Pharmaceutical Manufacturing Initiatives, MIT-CBI

Break (10:00 AM – 10:15 AM)
Invited Presentations (10:15 AM – 12:15 PM)
Opportunities, Strategies and Tools for Innovation in BiomanufacturingWhile incremental improvements to manufacturing processes are consistently occurring, there have been few innovative breakthroughs in biomanufacturing. The pressure to adequately meet regulatory and safety standards while also increasing productivity to meet demand has created an innovation bottleneck. Given these constraints, what opportunities for innovation exist in biomanufacturing? What new tools and strategies can both enable and speed the implementation of innovation? What areas in manufacturing offer the greatest potential for gain through new innovations? This session aims to address these questions through invited talks.

J. Christopher Love (10:15 AM – 10:55 AM)
Latham Family Career Development Associate Professor of Chemical Engineering, MIT
“Novel Single-Cell Assays as Tools in Biopharmaceutical Manufacturing”

Richard Braatz (10:55 AM – 11:35 AM)
Edwin R. Gilliland Professor of Chemical Engineering, MIT
“Quality by Design Approaches for Pharmaceutical and Biopharmaceutical Manufacturing Processes”

Michael S. Strano (11:35 AM – 12:15 PM)
Charles and Hilda Roddey Associate Professor of Chemical Engineering, MIT
“Nanosensor Arrays for Glycan Profiling of Biologics and Understanding Cell Signaling”

Networking Lunch and Poster Session – Bartos Theater Lobby (12:15 PM – 1:30 PM)
Invited Presentations (1:30 PM – 3:30 PM)
Opportunities, Strategies and Tools for Innovation in BiomanufacturingBrian W. Anthony (1:30 PM – 1:50 PM)
Director, Master of Engineering in Manufacturing Program, Laboratory for Manufacturing Productivity, MIT
“Bio-manufacturing Instrumentation and Process Control”

Matthew D. Pietrzykowski (1:50 PM – 2:30 PM)
Lead Scientist, Ecoassessment Center of Excellence, GE Global Research
William Flanagan
Leader, Ecoassessment Center of Excellence, GE Global Research
“An Environmental Life Cycle Assessment Comparison of Single Use and Conventional Process Technology for the Production of Monoclonal Antibodies”

Oliver de Weck (2:30 PM – 2:50 PM)
Associate Professor of Aeronautics and Astronautics and Engineering Systems, MIT; Executive Director, MIT Production in the Innovation Economy (PIE) Study; Co-Director, Center for Complex Engineering Systems at KACST and MIT
“Production in the Innovation Economy (PIE): Overview of a major new MIT Initiative in Manufacturing”

Bernhardt Trout (2:50 PM – 3:30 PM)
Professor of Chemical Engineering; Director, Novartis-MIT Center for Continuous Manufacturing, MIT
“Protein Aggregation Modeling and Novel Excipients for Downstream Processing”

Break (3:30 PM – 3:45 PM)
Panel Discussion (3:45 PM – 5:00 PM)

How do we Innovate in Downstream Processing?
Antibody titers have improved 100 fold over two decades of development. However, this improvement in production has not been matched by downstream purification components. Protein purification costs become more pronounced as titers increase, with separation yields and materials costs becoming significant cost drivers. Yet, there have been few innovative breakthroughs in downstream processing, and current unit operations have been relatively unchanged over two decades. This panel aims to address the question: what are the opportunities for innovation in the separation and purification of biologics to remove the downstream processing bottleneck?

Panelists Include:
Anthony DiLeo
, Director of Corporate Technology, Millipore Corporation
Konstantin Konstantinov, VP Commercial Process Development, Genzyme
Thomas Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.; Consultant, Tarpon Biosystems
Bernhardt Trout, Professor of Chemical Engineering; Director, Novartis-MIT Center for Continuous Manufacturing, MIT

Moderated by Charles Cooney, Robert T. Haslam Professor of Chemical Engineering, MIT

Closing Remarks (5:00 PM – 5:15 PM)
Networking Poster Session in Lobby (5:15 PM – 6:30 PM)