手持拉曼光谱仪在抗体类药物鉴别中的应用研究  

Application of Handheld Raman Spectrometer in the Identification of Antibody Drugs

作　　者：段茂芹 于传飞[1] 付志浩[1] 梅玉婷 王兰[1] Duan Maoqin;Yu Chuanfei;Fu Zhihao;Mei Yuting;Wang Lan(National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定及标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《中国药事》2023年第10期1160-1171,共12页Chinese Pharmaceutical Affairs

摘　　要：目的:基于主成分分析(PCA)算法的Trutools模式,利用手持拉曼光谱仪建立快速鉴别抗体类药物的方法。方法:通过选取抗PD-1抗体、抗VEGF抗体、抗Her-2抗体,采集拉曼光谱数据,建立数据模型,分别对3种抗体进行鉴别。选择其中一种抗PD-1抗体,采用加热和光照两种条件对其进行加速降解处理,利用手持拉曼光谱仪对加速降解的抗体进行检测,研究所建方法能否检出加速降解的抗体。并通过分子排阻色谱(SEC-HPLC)、离子交换色谱(IEC-HPLC)及竞争结合酶联免疫吸附测定(ELISA)法对加速降解的抗体进行检测,与拉曼光谱检测结果进行比较。结果:通过建立的拉曼光谱数据模型可以鉴别3种不同类型的抗体,且拉曼光谱可以鉴别加速降解后的抗PD-1抗体。结论:手持拉曼光谱仪可以用来快速鉴别抗体类药物。本研究首次将手持拉曼光谱仪引入到抗体药物大分子检测中,为抗体类药物的现场快速鉴别及打假工作提供了新的工具与方法。Objective:To establish a rapid identification method for antibody drugs by using handheld Raman spectrometer based on Trutools model of principal component analysis(PCA)algorithm.Methods:Raman spectrum data were collected with anti-PD1 antibody,anti-VEGF antibody and anti-HER2 antibody,and the model was established to identify these three antibodies.The accelerated degradation of anti-PD1 antibody was disposed of heating and light conditions,and the accelerated degradation antibody was tested by handheld Raman spectrometer.The antibody was detected by size exclusion chromatography(SEC-HPLC),ion exchange chromatography(IEC-HPLC)and competitive binding enzyme-linked immunosorbent assay(ELISA),and the results were compared with those of Raman spectroscopy.Results:Three different types of antibodies can be identified by the established Raman spectroscopy data model,and the accelerated degradation of anti-PD1 antibody can be identified by Raman spectroscopy.Conclusion:Handheld Raman spectrometer can rapidly identify antibody drugs and be introduced into the test of antibody macromolecule drugs for the first time,providing a new tool and method for the rapid identification of antibodies and anti-counterfeiting work.

关 键 词：主成分分析(PCA)算法 拉曼光谱 抗体 分子排阻色谱 离子交换色谱 竞争结合酶联免疫吸附测定法 鉴别 

分 类 号：R917[医药卫生—药物分析学]