Challenge of CMC Regulatory Compliance for Biopharmaceuticals

ISBN-10: 1461469155
ISBN-13: 9781461469155
Edition: 2nd 2013
Authors: John Geigert
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Description: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It  More...

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Book details

Edition: 2nd
Copyright year: 2013
Publisher: Springer London, Limited
Publication date: 5/7/2013
Binding: Hardcover
Pages: 338
Size: 7.50" wide x 10.50" long x 1.00" tall
Weight: 2.574
Language: English

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

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