The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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...
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| Hlavní autor: | |
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| Korporativní autor: | |
| Médium: | Elektronický zdroj E-kniha |
| Jazyk: | English |
| Vydáno: |
New York, NY :
Springer New York : Imprint: Springer,
2013.
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| Vydání: | 2nd ed. 2013. |
| Témata: | |
| On-line přístup: | https://doi.org/10.1007/978-1-4614-6916-2 |
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Obsah:
- 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.