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ENGLISH - Continuous Manufacturing of Biologics
Date
December 7, 2021
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Continuous Manufacturing (CM) of biologics has been a hot topic for recent years because it has a potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing. In addition, ICH Q13 reached to step 2 on July 27, and is expected to progress to step 4 next year. This session will discuss ICH Q13 updates and perspectives from regulators and industry for CM of biologics.
Session Chairs
BioMarin Pharmaceutical Inc.
PMDA-Pharmaceuticals and Medical Devices Agency
Speakers
PMDA-Pharmaceuticals and Medical Devices Agency
PMDA-Pharmaceuticals and Medical Devices Agency
Sanofi
Panel Members
Merck & Co., Inc.
Novo Nordisk Inc.
Chugai Pharmaceutical Co., Ltd.
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