The Challenge of CMC Regulatory Compliance for Biopharmaceuticals - John Geigert - Books - Springer International Publishing AG - 9783031319112 - June 16, 2024
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John Geigert
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Fourth Edition 2023 Edition

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In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.

573 pages, 1 Illustrations, black and white; XXXV, 573 p. 1 illus.

Media Books     Paperback Book   (Book with soft cover and glued back)
Released June 16, 2024
ISBN13 9783031319112
Publishers Springer International Publishing AG
Pages 573
Dimensions 150 × 220 × 10 mm   ·   914 g
Language German  

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