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Making monoclonal antobodies: A CMC strategy and QbD approach

Making monoclonal antobodies: A CMC strategy and QbD approach

No customer reviews yet ISBN 9781480072077

This book provides a general description of monoclonal antibody manufacturing process. The content of this book is consistent with the structure of regulatory filing Module 3 (Quality) - CMC (Chemistry, Manufacturing and Control). This book also discussed QbD (Quality by design) in Drug Substance process development.

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Pub dateOct 29, 2012
ISBN-101480072079
ISBN-139781480072077
LanguageEnglish
Last updated 2026-08-30 02:36
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