The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

• Main Author: Geigert, John (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: New York, NY : Springer New York : Imprint: Springer, 2013.
• Edition: 2nd ed. 2013.
• Subjects: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.; Biomedicine general.

An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery.  Through means of this 2nd edition, this no longer needs to occur.  A great deal of thanks goes to two regulatory authorities – the United States Food and Drug Administration (FDA) and the E...

Table of Contents:

• 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.