The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion prot...
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| Формат: | Электронный ресурс eКнига |
| Язык: | английский |
| Опубликовано: |
Cham :
Springer Nature Switzerland : Imprint: Springer,
2023.
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| Редактирование: | 4th ed. 2023. |
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| Online-ссылка: | https://doi.org/10.1007/978-3-031-31909-9 |
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Оглавление:
- Biopharmaceutical Landscape
- Regulatory Pathways Impacting Biopharmaceuticals
- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
- Risk Management of the Minimum CMC Regulatory Compliance Continuum
- Ever-Present Threat of Adventitious Agent Contamination
- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance
- Upstream Production of the Biopharmaceutical Drug Substance
- Downstream Purification of the Biopharmaceutical Drug Substance
- Manufacturing the Biopharmaceutical Drug Product
- Complex Process-Related Impurity Profiles
- Seemingly Endless Biomolecular Structural Variants
- Indispensable Potency (Biological Activity)
- Biopharmaceutical Critical Quality Attributes
- The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life
- The Challenge of Demonstrating Biopharmaceutical Product Comparability
- Strategic CMC-Focused Interactions with Regulatory Authorities.