The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 2nd ed. 2013 Edition

Ebook Details

Authors

John Geigert

Year 2013
Pages 338
Publisher Springer
Language en
ISBN 9781461469155
File Size 3.12 MB
File Format PDF
Download Counter 44
Amazon Link

Ebook 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 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.) QR Code Online