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portada Protein Instability at Interfaces During Drug Product Development: Fundamental Understanding, Evaluation, and Mitigation
Type
Physical Book
Publisher
Author
Language
English
Pages
338
Format
Hardcover
Dimensions
23.4x15.6x2.1 cm
Weight
0.66 kg.
ISBN13
9783030571764
Edition No.
1
Categories

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

Li, Jinjiang ; Krause, Mary E. ; Tu, Raymond (Author) · Springer · Hardcover

Protein Instability at Interfaces During Drug Product Development: Fundamental Understanding, Evaluation, and Mitigation - Li, Jinjiang ; Krause, Mary E. ; Tu, Raymond

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Synopsis "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 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.

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