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The challenge of CMC regulatory compliance for biopharmaceuticals and other biologics /

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Bibliographic Details
Main Author: Geigert, J. (John), 1948-
Format: eBook
Language:English
Published: New York, NY : Springer, [2013]
Edition:2nd ed.
Subjects:
Technology, Pharmaceutical > standards.
Technology, Pharmaceutical > legislation & jurisprudence.
Biological Factors.
Pharmaceutical biotechnology.
Pharmaceutical biotechnology industry > Law and legislation.
Pharmaceutical biotechnology > Quality control.
MEDICAL / Pharmacology.
Medicine.
Pharmaceutical technology.
Biomedicine.
Pharmaceutical Sciences/Technology.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Complexity of biologic CMC regulation
  • Biologics are not chemical drugs
  • An effective CMC strategy is possible
  • Challenge of adventitious agent control
  • Source materials for biologics
  • Manufacture of the biologic API
  • The biologic final product process
  • Complex process-related impurities
  • Molecular structural analysis
  • Functional activity (Potency)
  • Setting specifications and expiry dates
  • Demonstrating product comparability
  • CMC-focused regulatory meetings.