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Sudden onset of market and public health demands during in the face of global pandemic could lead to major capacity crunches causing production delays and/or unintended product quality outcomes. Holistic evaluation of process, facility, and operational requirements to identify potential bottlenecks is critical when planning for projected commercial manufacturing expansion (scale-up or scale-out) to ensure timely delivery of transformative therapies to patients with consistent product quality. Rapid advancement of C>s products and COVID-19 vaccines necessitated implementation of flexible and sustainable operational and facility designs. These could offer valuable learnings with operational aspects of individualized therapies possibly as challenging as those for the off-the-shelf products.
What are the best practices how firms incorporate effective end-to-end capacity planning? What are the regulatory expectations for capacity analysis and process expansion validation?
This session will invite regulatory and industry experts to discuss key considerations for end-to-end capacity planning mitigating supply chain vulnerabilities for cutting edge lifesaving therapies.
Ingrid Markovic, PhD
Senior Science Advisor, Office of the Center Director, CBER
U.S. FDA
Silver Spring, Maryland, United States
Alicia D. Collins
Senior Director, Cell Therapy Global Product Supply Planning and Management
Bristol Myers Squibb
Seattle, Washington, United States
Roger Nosal, MA
Vice President, GCMC
Pfizer
Groton, Connecticut, United States
Lily Y. Koo, PhD
Biomedical Engineer, CBER
U.S. FDA
Silver Spring, Maryland, United States
Sau (Larry) L. Lee, PhD
Deputy Director of Science, OPQ, CDER
U.S. FDA
Silver Spring, Maryland, United States
.jpg "Kimberly LW Schultz, PhD photo")
Kimberly LW Schultz, PhD
GTB CMC Reviewer, CBER
U.S. FDA
Silver Spring, Maryland, United States