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· 제목 : Protein Instability at Interfaces During Drug Product Development: Fundamental Understanding, Evaluation, and Mitigation (Paperback)
· 분류 : 외국도서 > 의학 > 약학
· ISBN : 9783030571795
· 쪽수 : 338쪽
· 출판일 : 2022-02-13
· 분류 : 외국도서 > 의학 > 약학
· ISBN : 9783030571795
· 쪽수 : 338쪽
· 출판일 : 2022-02-13
목차
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.?
