Immunocapture LC-MS methods for pharmacokinetics of large molecule drugs.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-04-01 Epub Date: 2024-02-13 DOI:10.4155/bio-2023-0261

Emily G Werth, David Roos, Elsy T Philip

引用次数: 0

Abstract

Implementation of immunocapture LC-MS methods to characterize the pharmacokinetic profile of large molecule drugs has become a widely used technique over the past decade. As the pharmaceutical industry strives for speediness into clinical development without jeopardizing quality, robust assays with generic application across the pipeline are becoming instrumental in bioanalysis, especially in early-stage development. This review highlights the capabilities and challenges involved in hybrid immunocapture LC-MS techniques and its continued applications in nonclinical and clinical pharmacokinetic assay design. This includes a comparison of LC-MS-based approaches to conventional ligand-binding assays and the driving demands in large molecule drug portfolios including growing sensitivity requirements and the unique challenges of new modalities requiring innovation in the bioanalytical laboratory.

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用于大分子药物药代动力学的免疫捕获 LC-MS 方法。

在过去十年中，采用免疫捕获 LC-MS 方法表征大分子药物的药代动力学特征已成为一种广泛应用的技术。随着制药业努力在不影响质量的前提下加快临床开发的速度，在整个管线中通用的强大检测方法正成为生物分析的重要手段，尤其是在早期开发阶段。本综述重点介绍了混合免疫捕获液相色谱-质谱技术及其在非临床和临床药代动力学检测设计中的持续应用所涉及的能力和挑战。其中包括基于 LC-MS 的方法与传统配体结合测定的比较，以及大分子药物组合的驱动需求，包括不断增长的灵敏度要求和需要生物分析实验室创新的新模式所带来的独特挑战。

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.