| 王建锋,乔玉玲,秦海燕,崔保峰,南建军,毛晓燕.应用CE-SDS测定抗CD52人源化单克隆抗体参比品单体纯度及非糖化重链比例[J].,2018,(15):2836-2840 |
| 应用CE-SDS测定抗CD52人源化单克隆抗体参比品单体纯度及非糖化重链比例 |
| CE-SDS were Applied to Determine Monomer Purity and Proportion of Non-glycosylated Heavy Chain in Reference Products of anti-CD52 Humanized Monoclonal Antibody |
| 投稿时间：2017-12-28 修订日期：2018-01-23 |
| DOI：10.13241/j.cnki.pmb.2018.15.007 |
| 中文关键词: 十二烷基苯硫酸钠-毛细管电泳 抗CD52人源单抗 单体纯度 非糖化重链比例 |
| 英文关键词: CE-SDS Anti-CD52 humanized monoclonal antibody Monomer purity Non-glycosylated heavy chain proportion |
| 基金项目:甘肃省科技厅重大专项（1502FKDA008） |
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| 中文摘要: |
| 摘要 目的：测定抗CD52人源单克隆抗体参比品单体纯度及非糖基化重链比例。方法：采用PA800 plus毛细管电泳系统，非还原十二烷基苯硫酸钠-毛细管电泳（CE-SDS）测定抗CD52人源单克隆抗体单体纯度，以及用还原CE-SDS电泳测定非糖化重链比例。结果：非还原CE-SDS三次测定单体纯度平均值为93.57%，主峰的迁移时间及修正峰面积百分比RSD分别为0.16%和0.19%；还原CE-SDS电泳重链修正峰面积百分比平均值为66.89%，修正峰面积百分比及迁移时间RSD分别为0.09%和0%；轻链修正峰面积百分比平均值为32.30%；轻链修正峰面积及迁移时间RSD分别为0%和0%；非糖基化重链修正峰面积百分比平均值为0.87%，修正峰面积百分比及迁移时间RSD分别为6.66%和0.27%。结论：CE-SDS测定抗CD52人源单抗单体纯度及非糖化重链比例实验结果偏差较小，表明结果准确可靠。 |
| 英文摘要: |
| ABSTRACT Objective: To determine the monomer purity and proportion of non-glycosylated heavy chain in reference productsanti- CD52 humanized monoclonal antibody. Methods: Using PA800 plus capillary electrophoresis system, Non-reduced CE-SDS were ap- plied to determine monomer purity and reduced CE-SDS were applied to determine non-glycosylated heavy chain in anti-CD52 human- ized monoclonal antibody. Results: Average value of monomer purity is 93.57% by Non-reduced CE-SDS in three times, RSD of migra- tion time of main peak and corrected area percent were 0.16% and 0.19% respectively. Average value of heavy chain corrected area per- cent is 66.89% by reduced CE-SDS in three times, RSD of migration time and corrected area percent of main peak were 0.09% and 0% respectively. Average value of light chain corrected area percent is 32.30% by reduced CE-SDS in three times, RSD of corrected area percent and migration time of main peak were 0% and 0% respectively. Average value of non-glycosylated heavy chain corrected area percent is 0.87% by reduced CE-SDS in three times, RSD of corrected area percent and migration time of main peak were 6.66% and 0.27% respectively. Conclusion: The data of using CE-SDS determine the monomer purity and proportion of non-glycosylated heavy chain in anti-CD52 humanized monoclonal antibody displayed a much small RSD, and manifested the result were accurate and reliable. |
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