The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

John Geigert (Autor)

Buch | Softcover

338 Seiten

2016 | Softcover reprint of the original 2nd ed. 2013
Springer-Verlag New York Inc.
978-1-4939-4399-9 (ISBN)

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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.)

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)).

Complexity of Biologica CMC Regulation.- Biologics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Source Materials for Biologics.- Manufacture of the Biologic API.- The Biologic Final Product Process.- Complex Process-Related Impurities.- Molecular Structural Analysis.- Functional Activity (Potency).- Setting Specifications and Expiry Dates.- Demonstrating Product Comparability.- CMC-Focused Regulatory Meetings.- References.

Erscheinungsdatum	11.08.2016
Zusatzinfo	17 Illustrations, color; 7 Illustrations, black and white; XXIX, 338 p. 24 illus., 17 illus. in color.
Verlagsort	New York
Sprache	englisch
Maße	178 x 254 mm
Themenwelt	Medizin / Pharmazie ► Pharmazie
	Naturwissenschaften ► Biologie ► Biochemie
	Naturwissenschaften ► Chemie ► Technische Chemie
	Technik
Schlagworte	2nd Edition • biopharmaceuticals • CMC • Geigert • Regulatory Compliance
ISBN-10	1-4939-4399-5 / 1493943995
ISBN-13	978-1-4939-4399-9 / 9781493943999
Zustand	Neuware