Comprehensive performance evaluation of ligand-binding assay-LC-MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442).

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-04-01 Epub Date: 2024-02-22 DOI:10.4155/bio-2023-0225

Yue Huang, Michael Shane Woolf, Chun-Chi Wang, Sami M Naser, Aaron M Wheeler, William R Mylott, Eric Ma, Anton I Rosenbaum

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引用次数: 0

Abstract

Aims: AZD7442 is a combination SARS-CoV-2 therapy comprising two co-dosed monoclonal antibodies. Materials & methods: The authors validated a hybrid ligand-binding assay-LC-MS/MS method for pharmacokinetic assessment of AZD7442 in human serum with nominal concentration range of each analyte of 0.300-30.0 μg/ml. Results: Validation results met current regulatory acceptance criteria. The validated method supported three clinical trials that spanned more than 17 months and ≥720 analytical runs (∼30,000 samples and ∼3000 incurred sample reanalyses per analyte). The data generated supported multiple health authority interactions, across the globe. AZD7442 (EVUSHELD) was approved in 12 countries for pre-exposure prophylaxis of COVID-19. Conclusion: The results reported here demonstrate the robust, high-throughput capability of the hybrid ligand-binding assay-LC-MS/MS approach being employed to support-next generation versions of EVUSHELD, AZD3152.

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共剂量单克隆抗 SARS-CoV-2 抗体（AZD7442）的配体结合测定-LC-MS/MS 方法的综合性能评价。

目的：AZD7442 是一种由两种共剂量单克隆抗体组成的 SARS-CoV-2 联合疗法。材料与方法：作者验证了一种混合配体结合测定-LC-MS/MS方法，用于评估人血清中AZD7442的药代动力学，每种分析物的标称浓度范围为0.300-30.0 μg/ml。结果验证结果符合现行的监管验收标准。经过验证的方法支持了三项临床试验，时间跨度超过 17 个月，分析运行次数≥720 次（每种分析物可检测 ∼30,000 个样品和 ∼3000 次发生的样品再分析）。所生成的数据为全球多个卫生机构的互动提供了支持。AZD7442（EVUSHELD）在12个国家获批用于COVID-19的暴露前预防。结论本文报告的结果表明，混合配体结合测定-LC-MS/MS方法具有强大的高通量能力，可用于支持下一代版本的 EVUSHELD、AZD3152。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.