CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls and patient safety concerns for viral vectors, non-viral vectors and genetically modified patient cells. Regulatory authorities, primarily the U.S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition. This book covers effective, risk-based, and current, CMC regulatory compliance strategies for biopharmaceuticals. In this 5th edition, updates include new information on source material control in the manufacturing of biopharmaceutical drug substances, critical process controls in the manufacturing of biopharmaceutical drug substances, and more. This book is intended for biopharmaceutical professionals.
Chapter 1: Ever-Increasing Landscape of Biopharmaceuticals.
Chapter 2:
Regulatory Authority Pathways for Biopharmaceutical CMC Compliance.
Chapter
3: Differences in CMC Regulatory Compliance Across the Biopharmaceutical
Landscape.
Chapter 4: Risk Management to Achieve the Minimum CMC Regulatory
Compliance Continuum.
Chapter 5: Ever-Present Threat of Adventitious Agent
Contamination.
Chapter 6: Raw Material Control in the Manufacture of the
Biopharmaceutical DS.
Chapter 7: Critical Control of Starting Material(s)
for Manufacturing the Biopharmaceutical Drug Substance.
Chapter 8: Upstream
Process Control in the Manufacture of the Biopharmaceutical Drug Substance.-
Chapter 9: Downstream Process Control in the Manufacture of the
Biopharmaceutical Drug Substance.
Chapter 10: Bioconjugation of
Protein-Based Biopharmaceutical Bulk Drug Substance.
Chapter 11: Process
Control in the Manufacture of the Biopharmaceutical Drug Product.
Chapter
12: Controlling Manufacturing to Reduce the Complex Process-Related
Impurities.
Chapter 13: Controlling Manufacturing to Reduce Product-Related
Structural Variants.
John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in Carlsbad, California. He has 50 years of experience within the biopharmaceutical industry developing Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategies for recombinant proteins, monoclonal antibodies, biosimilars, gene therapy vectors, and cellbased medicines. Dr. Geigert has 10 years Executive Management experience as Vice President, Quality & Executive Officer at IDEC Pharmaceuticals, and Vice President, Quality at Immunex. He now has served for 25 years as an international independent CMC regulatory compliance consultant. He is a past chair of the PDA Biopharmaceutical Advisory Board. Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 4th Edition (June 2023).
