The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

  • John¬†Geigert

Table of contents

  1. Front Matter
    Pages i-xxviii
  2. John Geigert
    Pages 1-31
  3. John Geigert
    Pages 53-87
  4. John Geigert
    Pages 89-141
  5. John Geigert
    Pages 143-176
  6. John Geigert
    Pages 177-208
  7. John Geigert
    Pages 209-230
  8. John Geigert
    Pages 231-260
  9. John Geigert
    Pages 261-285
  10. John Geigert
    Pages 287-310
  11. John Geigert
    Pages 311-329
  12. John Geigert
    Pages 331-354
  13. John Geigert
    Pages 355-380
  14. Back Matter
    Pages 423-426

About this book


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 engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.


pharmaceutical QA/QC F-I-H studies risk based clinical development biotech drugs biosimilars recombinant protein monoclonal antibodies CGT-cell and gene therpy products living genetically engineered viruses ATMPs-Advanced Therapy Medicinal Products RMAT-Regenerative Medicines Advanced Therapy PRIME-Priority medicines risk based clinical development

Authors and affiliations

  • John¬†Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

Bibliographic information