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Protein Instability at Interfaces During Drug Product Development = Fundamental Understanding, Evaluation, and Mitigation /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Protein Instability at Interfaces During Drug Product Development/ edited by Jinjiang Li, Mary E. Krause, Raymond Tu.
其他題名:	Fundamental Understanding, Evaluation, and Mitigation /
其他作者:	Tu, Raymond.
面頁冊數:	VIII, 338 p. 58 illus., 41 illus. in color.online resource. :
Contained By:	Springer Nature eBook
標題:	Theoretical and Computational Chemistry. -
電子資源:	https://doi.org/10.1007/978-3-030-57177-1
ISBN:	9783030571771

Protein Instability at Interfaces During Drug Product Development = Fundamental Understanding, Evaluation, and Mitigation /
Protein Instability at Interfaces During Drug Product DevelopmentFundamental Understanding, Evaluation, and Mitigation /[electronic resource] :edited by Jinjiang Li, Mary E. Krause, Raymond Tu. - 1st ed. 2021. - VIII, 338 p. 58 illus., 41 illus. in color.online resource. - AAPS Advances in the Pharmaceutical Sciences Series,432210-738X ;. - AAPS Advances in the Pharmaceutical Sciences Series,20.

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. .

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 drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas. .

ISBN: 9783030571771

Standard No.: 10.1007/978-3-030-57177-1doiSubjects--Topical Terms:

670313
Theoretical and Computational Chemistry.

LC Class. No.: RM1-950

Dewey Class. No.: 615

Protein Instability at Interfaces During Drug Product Development = Fundamental Understanding, Evaluation, and Mitigation /
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