ENGLISH

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

By John Geigert (auth.)

Book information

Publisher
Springer-Verlag New York
Year
2013
ISBN
978-1-4614-6915-5, 978-1-4614-6916-2
DOI
10.1007/978-1-4614-6916-2
Language
english
Format
PDF
Filesize
4 MB (4289228 bytes)
Edition
2
Pages
338\362
Orientation
yes
Scanned
yes
Time added
2013-10-21 03:33:25
Pharmaceutical Sciences/Technology; Biomedicine ge

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.)

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