Protein Instability at Interfaces During Drug Product Development Fundamental Understanding, Evaluation, and Mitigation
Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule dr...
| Other Authors: | , , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2021, 2021
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| Edition: | 1st ed. 2021 |
| Series: | AAPS Advances in the Pharmaceutical Sciences Series
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| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 1. Overview of the impact of protein interfacial instability on the development of biologic products
- 2. Protein adsorption at a gas-aqueous interface
- 3. Interfacial behaviors of proteins
- 4. Interfacial stresses during drug substance purification processes
- 5. Evaluation of interfacial stress during drug product development
- 6.Relating interfacial shear and dilatations stress-es to protein aggregation in mAbs
- 7. Analytical techniques for evaluating protein instability at interfaces
- 8. Analysis of aggregates and particles
- 9. Protein interfacial instability of mixing and lyophilization during drug product manufacturing process scale-up and tech transfer
- 10. Excipients: Characterization, purpose, and selection
- 11. Interfacial stress and proteins prepared in the solid state
- 12. Interfaces in protein drug delivery: device concern
- 13. Future perspectives.