MIT
CASSS

 

 

Agenda

Morning Session

 

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7:30 – 8:00 am Registration & Breakfast
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8:00 – 8:15 am

Welcome & Introduction
Anthony J. Sinskey | view bio
Faculty Director, MIT Center for Biomedical Innovation; Professor of Microbiology and Engineering Systems, MIT

 

Session Chair: James C. Leung | view bio
Senior Research Fellow, MIT Center for Biomedical Innovation

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8:15 – 9:15 am Keynote Presentations
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8:15 – 8:45 am Rohin Mhatre | view bio
Vice President, Biopharmaceutical Development, Biogen Idec
Biogen Idec Strategy for Process Control and Parametric Release | view abstract

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8:45 – 9:15 am J. Christopher Love | view bio
Associate Professor of Chemical Engineering, MIT
Towards Making Biologics on Demand | view abstract
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9:15 – 11:15 am

Perspectives of Ideal State of Real Time Release & Potential Benefits

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9:15 – 9:45 am Jeffrey C. Baker | view bio
Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation and Research, US FDA
Real Time Release in Biopharmaceutical Manufacturing | view abstract
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9:45 – 10:15 am David Sullivan | view bio
Director, Bioprocess R&D Pilot Plants, Pfizer
Real Time Release Testing of Monoclonal Antibodies: Everyone wants it, so what’s taking so long? | view abstract
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10:15 – 10:30 am Break
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10:30 – 10:45 am René Labatut | view bio
Vice President, Global Manufacturing Technology, sanofi pasteur
Real Time Release Perspective on Vaccines | view abstract
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10:45 – 11:15 am Gunnar Malmquist | view bio
Staff Scientist, GE Healthcare Life Sciences
Towards Real Time Release through Improved Process Understanding | view abstract
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11:15 am – 12:45 pm Case Studies of Real Time Release in Pharmaceutical & Biotechnology Industries
Objectives: Lessons learned from actual practices to highlight successes, benefits, potentials and opportunities as well as limitations and obstacles
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11:15 – 11:45 am Peter McDonnell | view bio
Senior Technical Director, Sanofi
Progress toward Real Time Release for a Complex Non-biologics Large Molecule API Produced by Continuous Manufacturing | view abstract
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11:45 am – 12:15 pm Jette Wypych | view bio
Scientific Director, Amgen
Approaches and Technologies towards Enabling “Real Time Release Testing” for Biologics | view abstract
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12:15 – 12:45 pm Michael O’Connor | view bio
Senior Scientist, Pfizer
Pfizer's Approach to Upstream Sampling and PAT as Future Enablers of Real Time Batch Release | view abstract
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12:45 – 2:00 pm Networking Lunch & Poster Session
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Afternoon Session  
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2:00 – 4:00 pm Case Studies and New Technology Supporting Real Time Release in Pharmaceutical & Biotechnology Industries
Objectives: Lessons learned from actual practices to highlight successes, benefits, potentials and opportunities as well as limitations and obstacles
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2:00 – 2:30 pm John Duguid | view bio
Principal Process/Analytical Scientist, Aastrom Biosciences
Rapid Microbiological Methods for Real Time Release of Autologous Cell Therapy Products | view abstract
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2:30 – 3:00 pm Kripa Ram | view bio
Vice President, Bioprocess and Manufacturing Sciences (R&D), MedImmune
The Use of Mathematical Modeling to Predict and Control pCO2 Levels in Cell Culture Bioreactors | view abstract
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3:00 – 3:30 pm Richard D. Braatz | view bio
Edwin R. Gilliland Professor of Chemical Engineering, MIT
A First-Principles Model-based Approach to Real-time Release | view abstract
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3:30 – 4:00 pm Rajeev J. Ram | view bio
Professor ofElectrical Engineering and Computer Science, MIT
Micro- and Nanotechnologies for Real Time Protein Characterization | view abstract
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4:00 – 4:15 pm Break
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4:15 – 5:30 pm Panel Discussion
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Moderated by Charles L. Cooney | view bio
Robert T. Haslam (1911) Professor of Chemical Engineering, Emeritus, MIT; Faculty Director, Emeritus, Deshpande Center for Technological Innovation, MIT

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Panelists

Joanne Beck | view bio
Vice President, Process Development, Shire

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Rohin Mhatre | view bio
Vice President, Biopharmaceutical Development, Biogen Idec

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  GK Raju | view bio
Chairman and CEO, LightPharma, Inc.
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  Michael J. Tarlov | view bio
Chief, Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards & Technology
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5:30 – 5:45 pm Closing Remarks
Stacy L. Springs
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Director, Biomanufacturing Program; Executive Director, Consortium on Adventitious Agent Contamination in Biomanufacturing, MIT Center for Biomedical Innovation
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5:45 – 7:00 pm Poster Awards & Networking Reception
 
 
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