| 引用本文: | 沈泓,冯一鸣,卜晨,孙晗,秦奕辉,王艳君,潘攀,张愫,李志豪,彭姣,何凯伦.国产芯片毛细管电泳仪性能研究及单克隆抗体分析应用[J].中国现代应用药学,2024,41(18):33-32. |
| ShenHong,FengYiming,BuChen,SunHan,QinYihui,WangYanjun,PanPan,Zhang Su,LiZhihao,PengJiao,HeKailun.Research on the performance and application of monoclonal antibodies analysis of domestic chip capillary electrophoresis instrument[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(18):33-32. |
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| 国产芯片毛细管电泳仪性能研究及单克隆抗体分析应用 |
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沈泓1, 冯一鸣2, 卜晨2, 孙晗1, 秦奕辉3, 王艳君3, 潘攀3, 张愫3, 李志豪4, 彭姣2, 何凯伦1
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1.浙江省食品药品检验研究院;2.聚光科技（杭州）股份有限公司;3.天境生物科技（杭州）有限公司;4.浙江工业大学
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| 摘要: |
| 本研究以PA800 Plus毛细管电泳仪为参照对象，对采用MCE-SDS原理的国内自主研发的芯片毛细管电泳仪(MCE-100)进行了性能参数比对研究及还原性单克隆抗体样品检测应用。方法：研究初期制备了人白蛋白和转铁蛋白参考品混合液作为非单抗类蛋白供试品，分别从线性、灵敏度、精密度等方面对国产芯片毛细管电泳仪进行了系统性考察，并进一步研究了国产芯片化毛细管电泳仪仪在还原性单克隆抗体蛋白样品检测的应用，同时进行了方法学验证。结果：研究显示，该国产芯片毛细管电泳仪具有良好的系统性能，能够快速、高通量的完成蛋白样品的检测分析。结论：该国产芯片毛细管电泳仪具备蛋白分析检测能力，可用于一般蛋白样品及单克隆抗体药物的纯度分析。 |
| 关键词: 国产化替代 毛细管电泳仪 MCE-SDS 方法验证 |
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| 基金项目:高通量毛细管电泳分析系统 |
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| Research on the performance and application of monoclonal antibodies analysis of domestic chip capillary electrophoresis instrument |
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ShenHong1, FengYiming2, BuChen2, SunHan1, QinYihui3, WangYanjun3, PanPan3, Zhang Su3, LiZhihao4, PengJiao2, HeKailun1
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1.Zhejiang Institute for Food and Drug Control;2.Focused Photonics (Hangzhou) Inc;3.TJ Biopharma (Hangzhou) Co., Ltd.;4.Zhejiang University of Technology
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| Abstract: |
| In this study, the performance parameters of the chip capillary electrophoresis instrument independently developed in China base on MCE-SDS were compared with the PA800 Plus capillary electrophoresis instrument，and the application of reducing monoclonal antibody sample detection with domestic capillary electrophoresis. METHODS A systematic examination of the domestic chip capillary electrophoresis apparatus in terms of linearity, sensitivity and precision using the mixture of human serum albumin and transferrin, Meanwhile, The application of domestic capillary electrophoresis instrumentation for the detection of reduced monoclonal antibody protein samples was further investigated, along with methodological validation. RESULTS The results showed that this domestic chip capillary electrophoresis instrument has good system performance and can complete the detection and analysis of protein samples quickly and in high throughput. CONCLUSION This domestic chip capillary electrophoresis instrument has the ability of protein analysis and detection, and can be used for the purity analysis of general protein samples and monoclonal antibody drugs. |
| Key words: domestic substitution capillary electrophoresis MCE-SDS method validation |
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