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The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals » (1st Edition)

Book cover image of The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals by J. Geigert

Authors: J. Geigert, John Geigert
ISBN-13: 9780306480409, ISBN-10: 0306480409
Format: Hardcover
Publisher: Springer-Verlag New York, LLC
Date Published: January 2004
Edition: 1st Edition

Author Biography: J. Geigert

Book Synopsis

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.

	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
	References