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Session 7B: Control Strategy in Continuous Manufacturing
Session Chair(s)
T. Venkateshwaran, PhD
Vice President and Global Head CMC Biologics, Medical Devices and Comb
Merck & Co., Inc., United States
Continuous manufacturing is the ability to process materials to a defined end state without any process interruptions. Continuous processes while prevalent in industries such as petrochemical manufacturing are a fairly innovative concept in the Pharmaceutical Industry. It is often seen as the next step in the cGMP’s for the 21st century initiative and is currently being explored by a number of companies. The advantages of continuous processing while many are also accompanied by some uncertainties. The purpose of this session is to focus on continuous manufacturing process and control strategies for continuous processing. The challenges as well as opportunities of continuous manufacturing will be discussed as part of the session.
Speaker(s)
Continuous Processing – A Regulatory Perspective
Sharmista Chatterjee, PhD
Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA, United States
Division Director in Division of Pharmaceutical Manufacturing II,
Implementation of Continuous Manufacturing in the Pharmaceutical Industry: Challenges and Opportunities
Nirdosh Jagota, PhD
GRQ Biotech Advisors LLC, United States
Managing Partner
Continuous Manufacturing: Is it Feasible or Not?
James Evans, PhD
Massachusetts Institute of Technology, United States
Associate Director, Novartis-MIT Center for Continuous Manufacturing
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