Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: "The What").

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS Bioanalysis Pub Date : 2024-11-06 DOI:10.1080/17576180.2024.2418250

Amanda Wilson, Mark Jean Gnoth, Nico van de Merbel, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman

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Abstract

Following up on our most recent discussion paper focusing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e., the what?) and another on the practical considerations (i.e., the how). In this paper, we discuss 'the what'. Both papers should be helpful for the bioanalytical community to better understand the challenges and provide an insight on why bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS should not be compared with the more traditional LC-MS/MS assay for small molecules or ligand binding assays for biotherapeutics.

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透视研究和监管生物分析中用于生物治疗和生物标记蛋白质的液相色谱-质谱联用仪（/MS）：欧洲生物分析论坛社区十多年来的经验总结（第 1 部分："什么"）。

欧洲生物分析论坛（European Bioanalysis Forum）最近发表了一篇讨论论文，重点探讨了使用 LC-MS/MS 进行生物治疗和生物标记蛋白质生物分析所面临的持续监管挑战。由于讨论的主题范围很广，这些信息分为两篇研究论文，一篇侧重于技术构建的基本原理（即 "是什么"），另一篇侧重于实际考虑因素（即 "如何做"）。在本文中，我们将讨论 "是什么"。这两篇论文将有助于生物分析界更好地理解所面临的挑战，并深入探讨为什么使用 LC-MS/MS 进行生物治疗和生物标记蛋白的生物分析不能与传统的小分子 LC-MS/MS 分析或生物治疗配体结合分析相提并论。

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.