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Session 7 Track B: Q13 Continuous Manufacturing
Session Chair(s)
Derek Vrieze, MSC
Senior Associate Regulatory-CMC
Vertex Pharmaceuticals, United States
This session focuses on perspectives of continuous manufacturing (CM) from both FDA and industry perspective. Vertex Pharmaceuticals will share learnings from the commercialization of 2 CM processes. FDA will summarize initiatives to support new developments in the manufacture of biotechnology products, the current state of CM and a forward looking discussion about new CM modalities and a brief discussion of ICH Q13.
Speaker(s)
A Fearless Approach to Continuous Manufacturing
Gregory Connelly
Vertex Pharmaceuticals, Inc., United States
Bioburden Control Strategy for Continuous Manufacturing: FDA’s Perspective
Scott Nichols, PHD
FDA CDER, United States
Microbiologist
FDA’s Perspective on the Advancement of Continuous Manufacturing
Rapti Madurawe
FDA, United States
Chemist