剪应力
生物制药
剪切(地质)
罪魁祸首
降级(电信)
生化工程
蛋白质降解
压力(语言学)
材料科学
化学
法律工程学
工程类
医学
复合材料
生物技术
生物
生物化学
内科学
哲学
电信
心肌梗塞
语言学
作者
Camilla Moino,Fiora Artusio,Roberto Pisano
标识
DOI:10.1016/j.ijpharm.2023.123679
摘要
Protein degradation is a major concern for protein-based therapeutics. It may alter the biological activity of the product and raise the potential for undesirable effects on the patients. Among the numerous drivers of protein degradation, shear stress has been the focus around which much work has revolved since the 1970s. In the pharmaceutical realm, the product is often processed through several unit operations, which include mixing, pumping, filtration, filling, and atomization. Nonetheless, the drug might be exposed to significant shear stresses, which might cooperatively contribute to product degradation, together with interfacial stress. This review presents fundamentals of shear stress about protein structure, followed by an overview of the drivers of product degradation. The impact of shear stress on protein stability in different unit operations is then presented, and recommendations for limiting the adverse effects on the biopharmaceutical formulations are outlined. Finally, several devices used to explore the effects of shear stress are discussed.
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