The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics /
| Main Author: | |
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| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
New York, NY :
Springer New York : Imprint: Springer,
2013.
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| Edition: | 2nd ed. 2013. |
| Subjects: |
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.