The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Paperback, Softcover reprint of the original 2nd ed. 2013)

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.)

General

Imprint:	Springer-Verlag New York
Country of origin:	United States
Release date:	August 2016
First published:	2013
Authors:	John Geigert
Dimensions:	254 x 178 x 25mm (L x W x T)
Format:	Paperback
Pages:	338
Edition:	Softcover reprint of the original 2nd ed. 2013
ISBN-13:	978-1-4939-4399-9
Categories:	Books > Medicine > General issues > Medical equipment & techniques > Medical research Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Promotions
LSN:	1-4939-4399-5
Barcode:	9781493943999

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