抗体类药物的生物分析方法研究概况

doi:10.12092/j.issn.1009-2501.2020.02.017

中国临床药理学与治疗学 ›› 2020, Vol. 25 ›› Issue (2): 227-232.doi: 10.12092/j.issn.1009-2501.2020.02.017

抗体类药物的生物分析方法研究概况

郑逢佳^1,2，贾志君³，谢新遥³，韩敏³，董立厚²

¹天津大学化工学院，天津300072； ²中国人民解放军军事科学院军事医学研究院生命组学研究所，北京102206； ³军科正源(北京)药物研究有限责任公司，北京102206

收稿日期:2019-12-12 修回日期:2020-01-29 出版日期:2020-02-26 发布日期:2020-03-06
通讯作者: 董立厚，男，博士，研究方向：生物技术药物药代动力学。 Tel:13241703103 E-mail: dlh9957001@sina.com
作者简介:郑逢佳，女，硕士研究生，研究方向：生物技术药物药代动力学。 Tel:13041023993 E-mail: 13041023993@163.com
基金资助:
国家“重大新药创制”科技重大专项资助项目（2020ZX09201026）

A surey of bioanalysis methods for antibody drugs

ZHENG Fengjia ^1,2, JIA Zhijun ³, XIE Xinyao ³, HAN Min³, DONG Lihou ²

¹ School of Chemical Engineering and Technology, Tianjin University, Tianjin 300072, China; ² State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences(Beijing), Beijing Institute of Lifeomics, Beijing 102206, China; ³Beijing United-Power PharmaTech Co. ,Ltd. ,Beijing 102206，China

Received:2019-12-12 Revised:2020-01-29 Online:2020-02-26 Published:2020-03-06

摘要/Abstract

摘要： 抗体类药物因其靶向性、高度特异性、低毒性等优点成为临床治疗众多疾病的首选药物，但在生物体内的处置机制有其特殊性和复杂性，极大地增加了生物检测的难度，因此必须建立灵敏、准确、可重复的测定方法。本文主要针对该类药物的生物分析方法，介绍酶联免疫吸附分析、电化学发光技术、液质联用技术、流式细胞术以及一些新技术方法的特点和应用概况，以期为研究此类药物提供参考。

关键词: 单克隆抗体, 生物分析方法, 液质联用技术, 流式细胞术

Abstract: Antibody drugs have become the first choice for clinical treatment of many diseases due to their advantages of targeting, high specificity and low toxicity. However, the disposal mechanism in vivo has its particularity and complexity, which greatly increases the difficulty of biological detection. Therefore, to establish the sensitive, accurate and repeatable methods is urgent. This paper mainly focuses on the bioanalytical methods of this kind of drugs, introduces the characteristics and application of enzyme-linked immunosorbent assay, electrochemiluminescence, liquid chromatography-mass spectrometry, flow cytometry and some new techniques, in hope of providing a reference for the study of related drugs.

Key words: monoclonal antibody, bioanalytical methods, LC-MS/MS, flow cytometry

中图分类号:

R917

郑逢佳，贾志君，谢新遥，韩敏，董立厚. 抗体类药物的生物分析方法研究概况[J]. 中国临床药理学与治疗学, 2020, 25(2): 227-232.

ZHENG Fengjia, JIA Zhijun, XIE Xinyao, HAN Min, DONG Lihou. A surey of bioanalysis methods for antibody drugs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(2): 227-232.

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抗体类药物的生物分析方法研究概况

A surey of bioanalysis methods for antibody drugs

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