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...

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Bibliographic Details
Other Authors: Li, Jinjiang (Editor), Krause, Mary E. (Editor), Tu, Raymond (Editor)
Format: eBook
Language:English
Published: Cham Springer International Publishing 2021, 2021
Edition:1st ed. 2021
Series:AAPS Advances in the Pharmaceutical Sciences Series
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Description
Summary: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 surfacescience, pharmaceutical, and medicinal chemistry areas.
Physical Description:VIII, 338 p. 58 illus., 41 illus. in color online resource
ISBN:9783030571771