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。

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis 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

摘要

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。

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

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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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.