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Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Geigert, J

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Available: Yes*
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Book Information
Edition:	3rd
Publisher:	Plenum Publishing Corporation
ISBN:	3-030-13754-6 (3030137546)
ISBN-13:	978-3-030-13754-0 (9783030137540)
Binding:	E E Book + ProQuest Ebook Central
Copyright:	2019
Publish Date:	06/19
Weight:	0.00 Lbs.
Subject Class:	PHM (Pharmacy and Pharmaceutical Industry)
Return Policy:	Non-Returnable.

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Class Specifications
Discipline:	Pharmacology
Subject Definition:	Tech, Pharm; Drug Industry-Legis & Juris
NLM Class:	QV 778
LC Class:	RS380
Abstract:	Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products.

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