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Intact Protein Mass Spectrometry for Therapeutic Protein Quantitation, Pharmacokinetics, and Biotransformation in Preclinical and Clinical Studies: An Industry Perspective.
Journal of the American Society for Mass Spectrometry ( IF 3.2 ) Pub Date : 2020-09-15 , DOI: 10.1021/jasms.0c00270
John F Kellie 1 , John C Tran 2 , Wenying Jian 3 , Barry Jones 4 , John T Mehl 5 , Ying Ge 6 , Jack Henion 7 , Kevin P Bateman 8
Affiliation  

Recent advancements in immunocapture methods and mass spectrometer technology have enabled intact protein mass spectrometry to be applied for the characterization of antibodies and other large biotherapeutics from in-life studies. Protein molecules have not been traditionally studied by intact mass or screened for catabolites in the same manner as small molecules, but the landscape has changed. Researchers have presented methods that can be applied to the drug discovery and development stages, and others are exploring the possibilities of the new approaches. However, a wide variety of options for assay development exists without clear recommendation on best practice, and data processing workflows may have limitations depending on the vendor. In this perspective, we share experiences and recommendations for current and future application of mass spectrometry for biotherapeutic molecule monitoring from preclinical and clinical studies.

中文翻译:

用于临床前和临床研究中治疗性蛋白质定量、药代动力学和生物转化的完整蛋白质质谱:行业视角。

免疫捕获方法和质谱仪技术的最新进展使完整蛋白质质谱法能够应用于表征抗体和其他大型生物治疗药物的生命研究。蛋白质分子传统上并未通过完整质量进行研究或以与小分子相同的方式筛选分解代谢物,但情况已发生变化。研究人员提出了可应用于药物发现和开发阶段的方法,其他人正在探索新方法的可能性。然而,在没有关于最佳实践的明确建议的情况下,存在各种各样的检测开发选项,并且数据处理工作流程可能有限制,具体取决于供应商。从这个角度来看,
更新日期:2020-09-01
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