The challenge of CMC regulatory compliance for biopharmaceuticals

The challenge of CMC regulatory compliance for biopharmaceuticals / John Geigert.

Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion prot...

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Bibliographic Details
Main Author: Geigert, J. (John), 1948- (Author)
Format: eBook
Language:English
Published: Cham : Springer, [2023]
Edition:Fourth edition.
Subjects:
Pharmaceutical biotechnology industry > Law and legislation.
Pharmaceutical biotechnology > Quality control.
Pharmaceutical biotechnology industry > Law and legislation
Pharmaceutical biotechnology > Quality control
Online Access:Click for online access
Table of Contents:
  • Biopharmaceutical Landscape
  • Regulatory Pathways Impacting Biopharmaceuticals
  • Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
  • Risk Management of the Minimum CMC Regulatory Compliance Continuum
  • Ever-Present Threat of Adventitious Agent Contamination
  • Starting Materials for Manufacturing the Biopharmaceutical Drug Substance
  • Upstream Production of the Biopharmaceutical Drug Substance
  • Downstream Purification of the Biopharmaceutical Drug Substance
  • Manufacturing the Biopharmaceutical Drug Product
  • Complex Process-Related Impurity Profiles
  • Seemingly Endless Biomolecular Structural Variants
  • Indispensable Potency (Biological Activity)
  • Biopharmaceutical Critical Quality Attributes
  • The Art of Setting Biopharmaceutical Specifications ⁰́₃ Release and Shelf-Life
  • The Challenge of Demonstrating Biopharmaceutical Product Comparability
  • Strategic CMC-Focused Interactions with Regulatory Authorities.

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