Technical The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (9780306480409)

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Author: John Geigert
Publisher: Plenum Publishing Corporation
Publish Date: 2004
ISBN: 9780306480409
Pages: 386

Provides insight and practical suggesting in a common sense business approach for managing the Chemistry, Manufacturing & Controls (CMC) regulatory compliance requirements for biopharmaceuticals. Explains the biopharmaceutical CMC regulatory compliance, strategy development, and more.

	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

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	Business/Investing The IT Regulatory and Standards Compliance Handbook:: How to Survive Information Systems Audit and Assessments Craig S. Wright “The IT Regulatory and Standards Compliance Handbook:How to Survive Information Systems Audit and Assessments" Syngress \| 2008-06-21 \| ISBN: 1597492663 \| 750 pages \| PDF \| 10,7 MB This book provides comprehensive method ...
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