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Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Geigert, J
Challenge of CMC Regulatory Compliance for Biopharmaceuticals Cover Image
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Book Information
Edition: 3rd
Publisher: Plenum Publishing Corporation
ISBN: 3-030-13753-8 (3030137538)
ISBN-13: 978-3-030-13753-3 (9783030137533)
Old Edition: 0-306-48040-9
Binding: Hardcover
Copyright: 2019
Publish Date: 06/19
Weight: 0.00 Lbs.
Subject Class: PHM (Pharmacy and Pharmaceutical Industry)
Return Policy: Returns accepted up to 12 months provided no other recalls or return restrictions apply.
Contributing Authors: View
 
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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