Fit-for-purpose application of LC-MS in protein bioanalysis, case studies shared within the European Bioanalysis Forum Hybrid MS team.

IF 2.1 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2026-05-01 Epub Date: 2026-06-24 DOI:10.1080/17576180.2026.2683269

Amanda Wilson, Richard Lucey, Emmanuel Njumbe Ediage, Katrin Schroeter, Szabolcs Szarka, Peter Blattmann, Paul Boersema, Kees Bronsema, Gregor Jordan, Sebastian Malchow, David Pekar, Heike Wiese, Bryan Marks, Frank Schalk, Marie Reille-Seroussi, Ana Villar Garea, Nico van de Merbel, Lieve Dillen, Philip Timmerman

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引用次数: 0

Abstract

The use of liquid chromatography-mass spectrometry for quantitative large-molecule bioanalysis has increased substantially over the past decade, driven by its ability to address analytical challenges that may be difficult to resolve using traditional ligand-binding assays. In this European Bioanalysis Forum perspective, seven case studies from pharmaceutical companies and contract research organizations illustrate the fit-for-purpose application of LC-MS across different stages of drug development. These include isoform-specific quantification, subclass-resolved immunoglobulin profiling, characterization of post-translational modifications, assessment of in vivo biotherapeutic integrity, and multiplexed analysis in complex biological matrices. Collectively, the examples highlight how LC-MS can support selectivity, structural insight, and analytical flexibility when aligned with the specific context of use. The EBF aims to foster continued scientific exchange by encouraging the sharing of such case studies across its community.

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符合目的的LC-MS在蛋白质生物分析中的应用，在欧洲生物分析论坛混合质谱团队中分享的案例研究。

在过去的十年中，液相色谱-质谱法在定量大分子生物分析中的应用大幅增加，这是由于它能够解决传统配体结合测定法可能难以解决的分析挑战。从欧洲生物分析论坛的角度来看，来自制药公司和合同研究组织的七个案例研究说明了LC-MS在药物开发不同阶段的合适应用。这些包括异构体特异性定量，亚类分辨免疫球蛋白谱，翻译后修饰的表征，体内生物治疗完整性评估，以及复杂生物基质中的多重分析。总的来说，这些例子突出了LC-MS在与特定使用环境相一致时如何支持选择性、结构洞察力和分析灵活性。EBF旨在通过鼓励在其社区内分享此类案例研究来促进持续的科学交流。

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.