Wilson Amanda, Gnoth Mark Jean, de Merbel Nico van, Blattmann Peter, Ingelse Benno, Jordan Gregor, Fusetti Fabrizia, Blackburn Michael, Sporring Sune Hove, Love Iain, Muccio Stephane, Barfield Matthew, Wheller Rob, Timmerman Philip
Labcorp Early Development Laboratories Limited, Bioanalytical Services Harrogate, HG3 1PY, United Kingdom employed by AstraZeneca, Cambridge, CB21 6GH, United Kingdom during the writing of the manuscript.
Bayer, DMPK, in vivo PK and bioanalytics, Bayer AG, 42096, Wuppertal, Germany.
Bioanalysis. 2025 Jan;17(2):63-70. doi: 10.1080/17576180.2024.2418250. Epub 2024 Nov 6.
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.
在我们最近一篇聚焦于生物治疗和生物标志物蛋白质的液相色谱-串联质谱（LC-MS/MS）生物分析持续面临的监管挑战的讨论文件基础上，欧洲生物分析论坛汇报了其关于生物治疗和生物标志物蛋白质在研究及规范生物分析中的方法开发的内部讨论及经验。由于所讨论的主题范围广泛，这些信息分布在两篇研究论文中，其中一篇聚焦于该技术所基于的基本原理（即是什么？），另一篇则关注实际考量（即如何做？）。在本文中，我们讨论“是什么”。这两篇论文应有助于生物分析领域更好地理解这些挑战，并深入了解为何生物治疗和生物标志物蛋白质的LC-MS/MS生物分析不应与针对小分子的更传统的LC-MS/MS分析或针对生物治疗药物的配体结合分析相比较。
