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用于生物制药的抗药物抗体的检测和分析方法:综述。

Approaches for the detection and analysis of antidrug antibodies to biopharmaceuticals: A review.

机构信息

Department of Chemistry, University of Nebraska-Lincoln, Lincoln, Nebraska, USA.

出版信息

J Sep Sci. 2022 Jun;45(12):2077-2092. doi: 10.1002/jssc.202200112. Epub 2022 Mar 10.

Abstract

Antibody-based therapeutic agents and other biopharmaceuticals are now used in the treatment of many diseases. However, when these biopharmaceuticals are administrated to patients, an immune reaction may occur that can reduce the drug's efficacy and lead to adverse side-effects. The immunogenicity of biopharmaceuticals can be evaluated by detecting and measuring antibodies that have been produced against these drugs, or antidrug antibodies. Methods for antidrug antibody detection and analysis can be important during the selection of a therapeutic approach based on such drugs and is crucial when developing and testing new biopharmaceuticals. This review examines approaches that have been used for antidrug antibody detection, measurement, and characterization. Many of these approaches are based on immunoassays and antigen binding tests, including homogeneous mobility shift assays. Other techniques that have been used for the analysis of antidrug antibodies are capillary electrophoresis, reporter gene assays, surface plasmon resonance spectroscopy, and liquid chromatography-mass spectrometry. The general principles of each approach will be discussed, along with their recent applications with regards to antidrug antibody analysis.

摘要

抗体类治疗药物和其他生物制药如今被应用于多种疾病的治疗。然而,当这些生物制药被施用于患者时,可能会发生免疫反应,从而降低药物的疗效并导致不良反应。生物制药的免疫原性可以通过检测和测量针对这些药物产生的抗体,即抗药物抗体来评估。在基于此类药物选择治疗方法时,以及在开发和测试新的生物制药时,用于检测和分析抗药物抗体的方法可能非常重要。本文综述了用于抗药物抗体检测、测量和鉴定的方法。这些方法中有许多是基于免疫测定法和抗原结合试验的,包括均相迁移率变动分析。用于分析抗药物抗体的其他技术包括毛细管电泳、报告基因分析、表面等离子体共振光谱法和液相色谱-质谱法。本文将讨论每种方法的一般原理,以及它们在抗药物抗体分析方面的最新应用。

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