The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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))
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| Format: | eBook |
| Language: | English |
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New York, NY
Springer New York
2013, 2013
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| Edition: | 2nd ed. 2013 |
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| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
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