作者
Ian C Shieh, Yuan Cheng
发表日期
2021
期刊
Protein Instability at Interfaces During Drug Product Development: Fundamental Understanding, Evaluation, and Mitigation
页码范围
171-197
出版商
Springer International Publishing
简介
Proteins at interfaces present a number of analytical challenges, particularly in the context of biotherapeutic formulations. Proteins typically adsorb to interfaces in thin films or monolayers while being present at high concentrations in the bulk liquid, making sensitivity to behavior directly at the interface an important feature. Additionally, there are multiple timescales of interest, from milliseconds to days, meaning the analytical techniques for probing interfacial behavior need to be adaptable with respect to time resolution. Also, biotherapeutic formulations are usually multicomponent systems, so the techniques need to distinguish between the behavior of the therapeutic protein and other surface-active excipients included to stabilize the protein (e.g., polysorbates and poloxamers). Finally, proteins form amorphous films at interfaces that make traditional interfacial techniques, usually applied to lipids and other well …
引用总数
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IC Shieh, Y Cheng - Protein Instability at Interfaces During Drug Product …, 2021