聚山梨酯在治疗性抗体中应用和引发不溶性颗粒的研究概况

Overview of the Application of Polysorbates in Therapeutic Antibody and Its Induction of Insoluble Particles

关键词:  聚山梨酯  治疗性抗体  应用  质量  降解  不溶性颗粒

Key words:  polysorbates  therapeutic antibody  application  quality  degradation  insoluble particles

摘要:

聚山梨酯是治疗性抗体开发中常用的一类非离子型表面活性剂。近年来，因聚山梨酯能够引发治疗性抗体溶液中不溶性颗粒的产生，使其受到业界的关注。本文综述了聚山梨酯在治疗性抗体开发中的应用和其导致不溶性颗粒的风险点，即聚山梨酯的自身质量、接触材质、降解；然后本文提出了使用色谱法监控聚山梨酯质量是更有利的技术；最后基于目前的研究提出解决此类不溶性颗粒的思路和其中现存的挑战，为聚山梨酯在治疗性抗体中应用前景做出参考。

Abstract:

Polysorbate is a commonly used non-ionic surfactant in the development of therapeutic antibodies. In recent years, polysorbate has attracted industry attention due to its ability to induce the production of insoluble particles in therapeutic antibody solutions. This article offers a comprehensive synopsis of polysorbate’s role in therapeutic antibody development and associated risks of insoluble particle formation, including its intrinsic mass, interacting material, and degradation. Subsequently, the merits of employing chromatography to supervise polysorbate quality are underscored. Finally, based on current research, a solution to this type of insoluble particle and the existing challenges are proposed, providing reference for the application prospects of polysorbate in therapeutic antibodies.