The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.  Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee.  Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

Complexity of Biologica CMC Regulation.- Biologics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Source Materials for Biologics.- Manufacture of the Biologic API.- The Biologic Final Product Process.- Complex Process-Related Impurities.- Molecular Structural Analysis.- Functional Activity (Potency).- Setting Specifications and Expiry Dates.- Demonstrating Product Comparability.- CMC-Focused Regulatory Meetings.- References.