利用疏水性主容器表面,减少单克隆抗体溶液中因流体剪切而形成的微粒。

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Xinyue Wang , Junjie Wang , Yang Han , Xingchun Jiang , Sixian Cao , Dongze Xu , Tiancheng Xiong , Xiang Guo , Cui Wang , Sha Guo , Hongying Song , Ting Dong , Le Zhang , Zhenming An , Jun Liu , Jing Han , Hao Wu
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引用次数: 0

摘要

蛋白质分子暴露于界面可能会导致蛋白质配方中蛋白质的聚集和颗粒的形成,尤其是疏水性界面可能会促进溶液中蛋白质的聚集。在这项研究中,我们发现通过使用疏水性十八烷基三氯硅烷(OTS)来改变表面性质,可以减少流体剪切力引起的蛋白质溶液中蛋白质聚集和颗粒的产生。通过蛋白质与疏水表面之间强烈的疏水作用,在疏水界面上形成了稳定的蛋白质吸附层,这可以防止聚集的蛋白质脱落到溶液中形成亚可见颗粒和不溶性蛋白质聚集体。此外,人类补体酶联免疫吸附试验结果表明,在 OTS 涂层容器中产生的颗粒不会激活人类补体,这表明 OTS 涂层容器可用作某些类型单克隆抗体制剂的主要容器。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Utilizing a hydrophobic primary container surface to reduce the formation of subvisible particles in monoclonal antibody solution caused by fluid shear

Utilizing a hydrophobic primary container surface to reduce the formation of subvisible particles in monoclonal antibody solution caused by fluid shear
The exposure of protein molecules to interfaces may cause protein aggregation and particle formation in protein formulations, especially hydrophobic interfaces, which may promote protein aggregation in solution. In this study, we found that modification of the surface properties by application of a hydrophobic Octadecyltrichlorosilane (OTS) could reduce the generation of protein aggregates and particles in protein solution induced by fluid shear. A stable protein adsorption layer was formed at the hydrophobic interface through the strong hydrophobic interaction between the protein and hydrophobic surface, which could prevent the aggregated protein from falling off into the bulk solution to form subvisible particles and insoluble protein aggregates. In addition, human complement enzyme linked immunosorbent assay results showed that the particles that were generated in the OTS-coated container did not activate human complement which indicated the OTS-coated container could be used as primary containers for certain types of monoclonal antibody formulation.
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来源期刊
CiteScore
8.80
自引率
4.10%
发文量
211
审稿时长
36 days
期刊介绍: The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.
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