Protein Instability at Interfaces During Drug Product Development
Broschiertes Buch

Protein Instability at Interfaces During Drug Product Development

Fundamental Understanding, Evaluation, and Mitigation

Herausgegeben: Li, Jinjiang; Krause, Mary E.; Tu, Raymond
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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 pro...