Comparable virus inactivation by bovine or vegetable derived Tween 80 during solvent/detergent treatment |
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| LI Ying, LI Jiaqi, YAO Xuejing, WANG Haina. Overview of the Application of Polysorbates in Therapeutic Antibody and Its Induction of Insoluble Particles[J]. Chinese Journal of Modern Applied Pharmacy, 2024, 41(3): 428-438. DOI: 10.13748/j.cnki.issn1007-7693.20222960 |
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| Authors: | LI Ying LI Jiaqi YAO Xuejing WANG Haina |
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| Affiliation: | 1.School of Pharmaceutical Sciences, Shandong University, Jinan 250012, China;2.RemeGen Co., Ltd., Yantai 264006, China |
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| 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. |
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| Keywords: | polysorbates therapeutic antibody application quality degradation insoluble particles |
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