Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production

Trevor Deeks

ISBN 10: 1942911173 ISBN 13: 9781942911173

Published by PDA/DHI, 2018

Used Hardcover

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About this Item

May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1942911173I4N00

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Synopsis:

This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process! Within this book, you can find chapters on: ~ Current manufacturing and process development of Regenerative Medicine Advanced Therapy Products (RMATs), or as they are known in the EU, Advanced Therapy Medicinal Products (ATMPs) ~ Quality systems and GMP requirements for Phase 1 to Phase 3 manufacturing ~ The impact of the Clinical Trials Directive on European GMP expectations and the role of the QP ~ The latest USP guidance on the transfer of analytical methods, validation and verification of compendial procedures ~ And, much more

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Bibliographic Details

Title: Phase Appropriate GMP for Biological ...
Publisher: PDA/DHI
Publication Date: 2018
Binding: Hardcover
Condition: Very Good
Dust Jacket Condition: No Jacket

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