Overview of the Application of Polysorbates in Therapeutic Antibody and Its Induction of Insoluble Particles
10.13748/j.cnki.issn1007-7693.20222960
- VernacularTitle: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
- Author:
Ying LI
1
;
Jiaqi LI
1
;
Xuejing YAO
2
;
Haina WANG
3
Author Information
1. School of Pharmaceutical Sciences, Shandong University, Jinan 250012, China;RemeGen Co., Ltd., Yantai 264006, China
2. RemeGen Co., Ltd., Yantai 264006, China
3. School of Pharmaceutical Sciences, Shandong University, Jinan 250012, China
- Publication Type:Journal Article
- Keywords:
polysorbates;
therapeutic antibody;
application;
quality;
degradation;
insoluble particles
- From:
Chinese Journal of Modern Applied Pharmacy
2024;41(3):428-438
- CountryChina
- Language:Chinese
-
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.
