The Challenge of CMC Regulatory Compliance for Biopharmaceuticals / Edition 1

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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.

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Product Details

  • ISBN-13: 9780306480409
  • Publisher: Springer-Verlag New York, LLC
  • Publication date: 12/31/2003
  • Edition description: Older Edition
  • Edition number: 1
  • Pages: 380
  • Product dimensions: 0.94 (w) x 7.00 (h) x 10.00 (d)

Meet 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)).

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Table of Contents

List of Tables
List of Figures
Ch. 1 Biopharmaceutical CMC Regulatory Compliance: What is It?
Ch. 2 Are Biopharmaceuticals Really Different?
Ch. 3 Developing the Corporate CMC Regulatory Compliance Strategy
Ch. 4 Can't Ignore cGMPs
Ch. 5 Recombinant Source Material: Master/Working Banks
Ch. 6 Production: Expansion of the Recombinant Organism and Expression of the Biopharmaceutical
Ch. 7 Purification of the Biopharmaceutical
Ch. 8 Biopharmaceutical Drug Product Manufacturing
Ch. 9 Physicochemical/Biological Analysis of the Biopharmaceutical Product
Ch. 10 Managing Process Changes - Demonstrating Product Comparability
Ch. 11 Biopharmaceutical CMC Outsourcing
Ch. 12 Concluding Thoughts on Biopharmaceutical CMC Regulatory Compliance
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