一种检测抗聚乙二醇抗体的单酸免疫原性方法:聚乙二醇化治疗的前后剂量。

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI:10.4155/bio-2023-0196
Issa Jyamubandi, Aanya Aamir, Jyotsna Kaur, Alen Sylvester, Richard Hughes, Sophia Li
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引用次数: 0

摘要

目的:预先存在的抗聚乙二醇(PEG)抗体(APAs)可能影响聚乙二醇化化合物的有效性和安全性。omonys®和Krystexxa®停药以及SARS-CoV-2 RNA疫苗过敏反应都与APAs有关。本项目旨在开发和验证一种检测PEG前和后总抗体的方法。材料和方法:重复的线性PEG结构阻止了桥接均质形式的使用,因此需要使用固相萃取和酸解离试验以及Meso Scale Discovery®平台。结果与结论:使用单酸盐分析,该方法被验证可以成功检测APA给药前和给药后,该方法的一个关键方面是制备适当的阴性对照。
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A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies.

Aim: Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compounds. Omontys® and Krystexxa® withdrawal and SARS-CoV-2 RNA vaccine anaphylaxis have all been linked to APAs. This project aimed to develop and validate a method to detect total antibodies against PEG, pre- and post-dose. Materials & methods: The repetitive, linear PEG structure prevented the use of a bridging homogenous format, hence the requirement to use a solid-phase extraction and acid dissociation assay coupled with the Meso Scale Discovery® platform. Results & conclusion: Using singlicate analysis, the method was validated to successfully detect APA pre- and post-dose, with a crucial aspect of the method being the preparation of an appropriate negative control.

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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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