Martos Ariadna, Koch Wendelin, Jiskoot Wim, Wuchner Klaus, Winter Gerhard, Friess Wolfgang, Hawe Andrea
Coriolis Pharma Research GmbH, Martinsried, Germany.
Coriolis Pharma Research GmbH, Martinsried, Germany; Division of Drug Delivery Technology, Cluster BioTherapeutics, Leiden Academic Centre for Drug Research, Universiteit Leiden, Leiden, The Netherlands.
J Pharm Sci. 2017 Jul;106(7):1722-1735. doi: 10.1016/j.xphs.2017.03.001. Epub 2017 Mar 14.
Among many other applications, polysorbates (PSs) are used as the most common surfactants in biopharmaceutical products in particular to protect proteins against interfacial stress. Structural heterogeneity, presence of degradants and other impurities, and tendency for degradation are interrelated features found in commercial PSs with a direct impact on their functional properties in biopharmaceutical products. These pose a challenge for the analytical characterization of PSs at different stages of product development. This review article focuses on methods and strategies reported in the recent years for the analytical characterization of PSs, their degradants and other impurities within neat PS (i.e., PS raw materials), diluted PS solutions, as well as in biopharmaceutical formulations. The use of versatile and complementary methods applied in a systematic approach is crucial to understand the impact of the concentration, composition, and degradation of PSs on the quality of biopharmaceutical products.
在许多其他应用中，聚山梨酯（PSs）是生物制药产品中最常用的表面活性剂，特别是用于保护蛋白质免受界面应力的影响。结构异质性、降解产物和其他杂质的存在以及降解趋势是商业PSs中相互关联的特征，直接影响它们在生物制药产品中的功能特性。这些给产品开发不同阶段的PSs分析表征带来了挑战。这篇综述文章重点关注近年来报道的用于分析表征PSs、其降解产物以及纯PS（即PS原料）、稀释的PS溶液以及生物制药制剂中的其他杂质的方法和策略。采用系统方法应用通用且互补的方法对于理解PSs的浓度、组成和降解对生物制药产品质量的影响至关重要。
