Authors:
Highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment
Presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing
Revised 2nd Edition is broadened to include biopharmaceuticals (biotech drugs) and other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Includes supplementary material: sn.pub/extras
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Table of contents (13 chapters)
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Front Matter
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Back Matter
About this book
Authors and Affiliations
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BioPharmaceutical Quality Solutions, Carlsbad, USA
John Geigert
About the author
John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee. Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).
Bibliographic Information
Book Title: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Authors: John Geigert
DOI: https://doi.org/10.1007/978-1-4614-6916-2
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: Springer Science+Business Media New York 2013
Hardcover ISBN: 978-1-4614-6915-5Published: 07 May 2013
Softcover ISBN: 978-1-4939-4399-9Published: 23 August 2016
eBook ISBN: 978-1-4614-6916-2Published: 08 July 2014
Edition Number: 2
Number of Pages: XXIX, 338
Number of Illustrations: 7 b/w illustrations, 17 illustrations in colour
Topics: Pharmaceutical Sciences/Technology, Biomedicine general