The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

This book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engine...

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Bibliographic Details
Main Author: Geigert, John (Author, http://id.loc.gov/vocabulary/relators/aut)
Corporate Author: SpringerLink (Online service)
Format: Electronic eBook
Language:English
Published: Cham : Springer International Publishing : Imprint: Springer, 2019.
Edition:3rd ed. 2019.
Subjects:
Pharmacology.
Pharmacy.
Pharmacology/Toxicology.
Drug Safety and Pharmacovigilance.
Online Access:Full Text via HEAL-Link
Table of Contents:
  • Complexity of Biologics CMC Regulation
  • Biopharmaceutics are Not Chemical Drugs
  • An Effective CMC Strategy is Possible
  • Challenge of Adventitious Agent Control
  • Biopharmaceutical Source Materials
  • Manufacturing of Biopharmaceutical APIs
  • Manufacturing of the Drug Product
  • Complex Process-Related Impurity Profiles
  • Product Characterization is a Journey
  • Priceless Potency (Therapeutic Activity)
  • Quality Attributes of a Biopharmaceutical
  • Designing the Stability Program
  • The Art of Setting Specifications
  • Demonstrating Product Comparability After Process Changes
  • Invaluable CMC-Focused Meetings with Regulatory Authorities.

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