The Challenge of CMC Regulatory Compliance for Biopharmaceuticals - John Geigert - Books - Springer Nature Switzerland AG - 9783032252821 - June 29, 2026
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John Geigert
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Fifth Edition 2026 edition

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CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls and patient safety concerns for viral vectors, non-viral vectors and genetically modified patient cells.

Regulatory authorities, primarily the U. S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition. This book covers effective, risk-based, and current, CMC regulatory compliance strategies for biopharmaceuticals.

In this 5th edition, updates include new information on source material control in the manufacturing of biopharmaceutical drug substances, critical process controls in the manufacturing of biopharmaceutical drug substances, and more. This book is intended for biopharmaceutical professionals.

Media Books     Hardcover Book   (Book with hard spine and cover)
To be released June 29, 2026
ISBN13 9783032252821
Publishers Springer Nature Switzerland AG
Pages 629
Dimensions 150 × 220 × 20 mm   ·   972 g   (Weight (estimated))

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