| 人源化抗叶酸受体抗体的抗原结合活性测定 |
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| 引用本文： | 范文红,毕华,王兰,饶春明.人源化抗叶酸受体抗体的抗原结合活性测定[J].药物分析杂志,2011(7). |
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| 作者姓名： | 范文红 毕华 王兰 饶春明 |
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| 作者单位： | 中国药品生物制品检定所重组技术产品室; |
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| 摘 要： | 目的:采用直接ELISA法检测人源化抗叶酸受体抗体的抗原结合活性。方法:以固定量的重组人叶酸受体a做包被抗原,辣根过氧化酶标记的抗人IgG(H+L)为二抗,直接测定不同浓度参比品和供试品与抗原的结合活性,通过数据处理软件对结果绘图,根据供试品及参比品EC50值计算供试品的相对结合力。结果:同一批次的3支供试品分别经3次测定,相对结合活性分别为参比品的(80.61±12.19)%,(88.82±12.70)%,(103.57±6.07)%,平均值(91.0±13.72)%。3次试验的RSD分别为15.12%,14.30%,5.86%。结论:直接ELISA法精密性良好,结果客观,影响因素少,可用于人源化叶酸受体抗体抗原结合活性的常规检测。
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| 关 键 词： | 生物制品 单克隆抗体 叶酸受体(FRA) 相对抗原结合力 酶联免疫分析 |
Measurement of the antigen binding activity of the humanized IgG1 antibody against alpha human folate receptor |
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| FAN Wen-hong,BI Hua,WANG Lan,RAO Chun-ming.Measurement of the antigen binding activity of the humanized IgG1 antibody against alpha human folate receptor[J].Chinese Journal of Pharmaceutical Analysis,2011(7). |
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| Authors: | FAN Wen-hong BI Hua WANG Lan RAO Chun-ming |
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| Institution: | FAN Wen-hong,BI Hua,WANG Lan,RAO Chun-ming(Department of Recombinant Technological Products,National Institute forthe Control of Pharmaceutical and Biological Products,Beijing 100050,China) |
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| Abstract: | Objective:To determine the antigen binding activity of the humanized IgG1 antibody against human folate receptor(FRA) alpha by ELISA directly.Methods:The reference and the samples of humanized antibody against human FRA were serially diluted and allowed to incubate with a fixed amount of human folate receptor alpha.The EC50 of reference standard and the samples would be determined by fitting a 4-parameter equation.The binding potency of the samples would be expressed as a percentage of the EC50 to that of t... |
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| Keywords: | biology products antibody folate receptor(FRA) relative binding potency ELISA |
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