| 段茂芹,于传飞,付志浩,梅玉婷,王兰.手持拉曼光谱仪在抗体类药物鉴别中的应用研究[J].中国药事,2023,(10):1160-1171 |
| 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 Identifi cation of Antibody Drugs |
| 投稿时间：2023-03-17 |
| DOI：10.16153/j.1002-7777.2023.10.008 |
| 中文关键词: 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 |
| 英文关键词: principal component analysis(PCA) Raman spectroscopy antibody size exclusion chromatography ion exchange chromatography competitive binding ELISA identifi cation |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: To establish a rapid identifi cation 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 identifi cation of antibodies and anti-counterfeiting work. |
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