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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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| 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 | view bio
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 |
