Challenge of CMC Regulatory Compliance for Biopharmaceuticals

John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in San Diego, California. He has over 40 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 20 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 3rd Edition (May 2019).

• 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 – Release and Shelf-Life.- The Challenge of Demonstrating Biopharmaceutical Product Comparability.- Strategic CMC-Focused Interactions with Regulatory Authorities.