| 对用于包被冠状动脉支架的抗CD34单克隆抗体的生物学指标的质量控制研究 |
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| 引用本文： | 张峰,郭玮,余占江,王佑春.对用于包被冠状动脉支架的抗CD34单克隆抗体的生物学指标的质量控制研究[J].药物分析杂志,2011(5). |
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| 作者姓名： | 张峰 郭玮 余占江 王佑春 |
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| 作者单位： | 中国药品生物制品检定所细胞室;乐普(北京)医疗器械股份有限公司; |
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| 摘 要： | 目的:对鼠源抗CD34单克隆抗体的结合活性以及包被在冠状动脉支架上的抗体量和牢固度等技术指标进行评价。方法:采用流式细胞术测定抗CD34单克隆抗体结合KG-1 a细胞的活性;酶联免疫显色方法测定支架上抗体包被量;体外模拟冲刷方法测定支架上抗体牢固度;采用显微镜计数方法测定包被抗CD34抗体支架体外捕获CD34(+)细胞的能力。结果:在抗CD34 M cAb浓度为1μg.mL-1时,细胞平均阳性率为96.34%;支架上抗体含量为50.97 ng.cm-2,而且体外模拟冲刷后支架上抗体含量无显著变化;包被抗CD34单抗的冠状动脉支架捕获细胞数为4万个.cm-2。结论:该方法可用于体外检测抗CD34单克隆抗体包被冠状动脉支架的生物学参数。
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| 关 键 词： | 单克隆抗体 支架 CD34 质量控制 |
Quality control of anti-CD34 monoclonal antibody used for coating coronary stents |
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| Institution: | ZHANG Feng1,GUO Wei1,Yü Zhan-jiang2,WANG You-chun1(1.National Institute for the Control of Pharmaceutical & Biological Products,Beijing 100050,China,2.Beijing LePu Medical Apparatus Inc.,Beijing 102200,China) |
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| Abstract: | Objective:To evaluate the biological parameters of anti-CD34 monoclonal antibody(McAb) used for coating coronary stents.Methods:KG-1a cell binding activity of anti-CD34 McAb was evaluated with flow cytometric methods;Coated quantity of McAb on coronary stents was measured with ELISA;The binding firmness of McAb was evaluated with wash simulation method;The CD34(+) KG-1a cell capture ability of anti-CD34 McAb coated on coronary stents was measured with microscope counting method.Results:When KG-1a cell was t... |
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| Keywords: | monoclonal antibody stent CD34 quality control |
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