John Geigert

(Author)

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (2013)Hardcover - 2013, 7 May 2013

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (2013)
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Print Length
338 pages
Language
English
Publisher
Springer
Date Published
7 May 2013
ISBN-10
1461469155
ISBN-13
9781461469155

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.)

Product Details

Author:
John Geigert
Book Edition:
2013
Book Format:
Hardcover
Country of Origin:
NL
Date Published:
7 May 2013
Dimensions:
25.4 x 18.54 x 2.54 cm
ISBN-10:
1461469155
ISBN-13:
9781461469155
Language:
English
Location:
New York, NY
Pages:
338
Publisher:
Weight:
1065.94 gm

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