碘[131I]爱克妥昔单抗注射液免疫反应活性的分析方法

    New Method to Inspection Immune Activity of Iodine[131I] Aiketuoxi Monoclonal Antibody Injection

    • 摘要: 研究建立了碘[131I]爱克妥昔单抗注射液免疫反应活性检验分析方法。用活细胞结合百分数法,对细胞选择、反应时间、反应温度和分离方法进行研究,并应用该方法分析爱克妥昔单抗注射液免疫活性的稳定性及批间变异系数。结果表明:选择CEA表达阳性的LS180活细胞,反应时间为16 h,反应温度为4 ℃,分离方法为直接分离法。该方法批间变异系数小于10%,重复性好,可以用于分析碘[131I]爱克妥昔单抗注射液的免疫反应活性。

       

      Abstract: A method for identifying the immuneactivity of iodine [131I]aiketuoxi monoclonal antibody injection was developed. The paper reported the method of percentage of living cells. Cell selection, the effect of temperature, time and separation method were studied, and as well as the stability of the product and the coefficient of variation were analysed by the method. The cell line was CEA expression positive LS180 cell, reaction time was 16 h, reaction temperature was 4 ℃, and it used a direct separation method. The variation coefficient of the method was less than 10%. The method has good reproducibility and can be used for analysis the immuneactivity of iodine [131I]aiketuoxi monoclonal antibody injection.

       

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