The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Fifth Edition 2026 Edition

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.

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 cell‐based 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).