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生物制品的稳定性与对聚山梨酯替代品的探索

Stability of Biologics and the Quest for Polysorbate Alternatives.

作者信息

Dubey Sachin, Giovannini Roberto

机构信息

Ichnos Sciences S.A., Chemin de la Combeta 5, La Chaux-de-Fonds, NE 2300, CH, Switzerland.

Ichnos Sciences S.A., Chemin de la Combeta 5, La Chaux-de-Fonds, NE 2300, CH, Switzerland.

出版信息

Trends Biotechnol. 2021 Jun;39(6):546-549. doi: 10.1016/j.tibtech.2020.10.007. Epub 2020 Oct 30.

DOI:10.1016/j.tibtech.2020.10.007
PMID:33139073
Abstract

Most biopharmaceutical formulations use polysorbates: surfactants that are highly efficient but difficult to manage in terms of compositional variability, quality, and stability. Alternatives, such as poloxamers, albumin, and cyclodextrin, are becoming popular and are being explored for their potential to protect biopharmaceuticals against physical and mechanical stresses.

摘要

大多数生物制药制剂使用聚山梨酯

这类表面活性剂效率很高,但在成分变异性、质量和稳定性方面难以管控。泊洛沙姆、白蛋白和环糊精等替代物正变得越来越受欢迎,人们正在探索它们保护生物制药免受物理和机械应力影响的潜力。

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Stability of Biologics and the Quest for Polysorbate Alternatives.生物制品的稳定性与对聚山梨酯替代品的探索
Trends Biotechnol. 2021 Jun;39(6):546-549. doi: 10.1016/j.tibtech.2020.10.007. Epub 2020 Oct 30.
2
Poloxamer 188 as surfactant in biological formulations - An alternative for polysorbate 20/80?泊洛沙姆188作为生物制剂中的表面活性剂——聚山梨酯20/80的替代品?
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Polysorbates versus Hydroxypropyl Beta-Cyclodextrin (HPβCD): Comparative Study on Excipient Stability and Stabilization Benefits on Monoclonal Antibodies.聚山梨酯与羟丙基-β-环糊精(HPβCD):赋形剂稳定性比较研究及对单克隆抗体的稳定作用。
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Acidic and alkaline hydrolysis of polysorbates under aqueous conditions: Towards understanding polysorbate degradation in biopharmaceutical formulations.在水相条件下聚山梨酯的酸碱性水解:探索聚山梨酯在生物制药制剂中的降解。
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Characterization of Polysorbate Ester Fractions and Implications in Protein Drug Product Stability.聚山梨酯酯级分的特性及其对蛋白药物产品稳定性的影响。
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Modular and tunable alternative surfactants for biopharmaceuticals provide insights into Surfactant's Structure-Function relationship.用于生物制药的模块化和可调替代表面活性剂为表面活性剂的结构-功能关系提供了深入了解。
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Investigating the Influence of Polysorbate 20/80 and Polaxomer P188 on the Surface & Interfacial Properties of Bovine Serum Albumin and Lysozyme.研究聚山梨酯 20/80 和泊洛沙姆 P188 对牛血清白蛋白和溶菌酶表面及界面性质的影响。
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Dynamic Properties of Novel Excipient Suggest Mechanism for Improved Performance in Liquid Stabilization of Protein Biologics.新型赋形剂的动态特性提示其可改善蛋白生物制剂的液体稳定性能的作用机制。
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引用本文的文献

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Competitive adsorption of a monoclonal antibody and amphiphilic polymers to the air-water interface.单克隆抗体与两亲性聚合物在气-水界面的竞争吸附。
Eur Biophys J. 2025 May 22. doi: 10.1007/s00249-025-01752-0.
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Defining Structure-Function Relationships of Amphiphilic Excipients Enables Rational Design of Ultra-Stable Biopharmaceuticals.定义两亲性辅料的结构-功能关系有助于合理设计超稳定生物制药。
Adv Sci (Weinh). 2025 Feb;12(8):e2409604. doi: 10.1002/advs.202409604. Epub 2025 Jan 7.
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Stability of Protein Pharmaceuticals: Recent Advances.
蛋白质类药物的稳定性:最新进展
Pharm Res. 2024 Jul;41(7):1301-1367. doi: 10.1007/s11095-024-03726-x. Epub 2024 Jun 27.
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Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and library.通过高效液相色谱-带电气溶胶检测法鉴别聚山梨醇酯20,并通过扩展化合物数据库和谱库对其成分进行表征。
J Pharm Anal. 2024 May;14(5):100929. doi: 10.1016/j.jpha.2023.12.019. Epub 2023 Dec 30.
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Oxidation of polysorbates - An underestimated degradation pathway?聚山梨酯的氧化——一种被低估的降解途径?
Int J Pharm X. 2023 Jul 27;6:100202. doi: 10.1016/j.ijpx.2023.100202. eCollection 2023 Dec 15.