Quality by Design Model for Biologics Drug Product Development

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A set of case studies on the different aspects of biologics drug product manufacturing, the book aims to help design manufacturing processes that meet the specific quality attributes of a product. Testing should be used to confirm the quality of the product, not to find out whether it met quality parameters or not. Addressing government implementation of QbD standards around the world, this timely reference emphasizes the application of QbD principles...

Format:Hardcover

Language:English

ISBN:0470887214

ISBN13:9780470887219

Release Date:May 2020

Publisher:Wiley

Length:300 Pages

Related Subjects

Medical Medical Books Science Science & Math Science & Scientists Science & Technology

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Quality by Design Model for Biologics Drug Product Development

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