Protein Instability at Interfaces During Drug Product Development
Fundamental Understanding, Evaluation, and Mitigation
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Beschreibung
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.
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 thesurface science, pharmaceutical, and medicinal chemistry areas.
Provides fundamental understanding of the behavior of proteins at interfaces Covers examples of protein interfacial activity in early development through product manufacture Includes an overview of analytical techniques for understanding interfacial activity of a given protein, as well as mitigation strategies
Autor*in
Jinjiang Li
Themen in »Protein Instability at Interfaces During Drug Product Development«
Protein purification drug delivery of biologics drug storage condiditons protein interfacial stress protein container compatability