×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
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
Have an account?