Regulated bioanalysis of antibody-drug conjugates using LC-MS.

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-04-01 Epub Date: 2025-04-09 DOI:10.1080/17576180.2025.2490468

Katsunori Ieki, Suguru Fukuda, Shiori Miyawaki, Kazunari Hirowatari

引用次数: 0

Abstract

Antibody-drug conjugates (ADCs) are emerging as powerful tools in cancer therapy. Evaluating their drug disposition requires the development and validation of analytical methods to obtain accurate quantitative results, which depend on understanding the ADC structural properties and selecting appropriate analytical platforms. Liquid chromatography-mass spectrometry (LC-MS) is a key technology for ADC bioanalysis, enabling the quantification of payloads, linkers, total antibodies, ADCs, and drug-to-antibody ratio (DAR). This review highlights the strategies and challenges in developing analytical methods for quantifying ADC components in biological samples using LC-MS with a focus on their constituent units. In addition, it addresses the validation requirements of these quantitative analytical methods during drug development.

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使用LC-MS进行抗体-药物偶联物的调节生物分析。

抗体-药物偶联物（adc）正在成为癌症治疗的有力工具。评估其药物处置需要开发和验证分析方法以获得准确的定量结果，这取决于了解ADC的结构特性和选择合适的分析平台。液相色谱-质谱（LC-MS）是ADC生物分析的一项关键技术，可以量化有效载荷、连接物、总抗体、ADC和药抗体比（DAR）。本文重点介绍了利用LC-MS定量生物样品中ADC成分的分析方法的策略和挑战，重点是它们的组成单位。此外，它解决了在药物开发过程中这些定量分析方法的验证要求。

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

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.