The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics - Geigert, John.; SpringerLink (Online service) (New York, NY : Springer New York : Imprint: Springer, 2013)
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.
Keywords: Pharmaceutical technology; Medicine; Pharmaceutical Sciences/Technology.; Biomedicine, general