CBI to Host Summit on Implementing Innovation in Biomanufacturing
MIT Center for Biomedical Innovation’s 4th Annual Biomanufacturing Summit
Implementing Innovation in Biomanufacturing: The Hurdles and the Opportunities
(November 18, 2011, 8:30am – 6:30pm)
Event Details:
Date: Friday, November 18th, 2011, Bartos Theater (Building E-15)
Time: 8:30 AM – 6:30 PM (registration starts at 8:00 AM)
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. The sessions for this year’s summit are:
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 bio-manufacturing? This session will attempt to answer this question through a panel discussion among experts. Topics include:
- Need for science and risk based approaches
- New analytical approaches for product and process characterization
- Post-translational modifications and 3D structures of protein products
- Protein aggregation
- Rapid immunogenicity assessment of protein products
- Emerging areas: follow-on biologics, nanotechnologies, and new process technologies
- Case studies and examples
Panelists Include: Dr. Jeffrey Baker, FDA; Professor Richard Braatz, MIT; Dr. Ajaz Hussain, PMI; Dr. Beth Junker, Merck; Professor J. Christopher Love, MIT; Dr. Ganesh Venkataraman, Momenta; Dr. G.K. Raju, MIT (Moderator)
Opportunities, Strategies and Tools for Innovation in Biomanufacturing
While 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 from:
- Brian W. Anthony, MIT – Bio-manufacturing Instrumentation and Process Control
- Prof. Richard Braatz, MIT – Quality by Design Approaches for Pharmaceutical and Biopharmaceutical Manufacturing Processes
- Prof. Oliver de Weck, MIT – Production in the Innovation Economy (PIE): Overview of a major new MIT Initiative in Manufacturing
- Prof. J. Christopher Love, MIT – Novel Single-cell Assays as Tools in Biopharmaceutical Manufacturing
- Matthew D. Pietrzykowski and Dr. William Flanagan, GE – An Environmental Life Cycle Assessment Comparison of Single Use and Conventional Process Technology for the Production of Monoclonal Antibodies
- Prof. Michael S. Strano, MIT – Nanosensor Arrays for Glycan Profiling of Biologics and Understanding Cell Signaling
- Prof. Bernhardt Trout, MIT – Protein Aggregation Modeling and Novel Excipients for Downstream Processing
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, Millipore Corporation; Dr. Konstantin Konstantinov, Genzyme; Thomas Ransohoff, Tarpon Biosystems; Professor Bernhardt Trout, MIT; Professor Charles Cooney, MIT (Moderator)