基于报告基因的抗 CSF-1R 抗体生物学活性测定方法建立

彦鹭 白(宝船生物医药科技（上海）有限公司，中国)
涛 王(宝船生物医药科技（上海）有限公司，中国)
婷 闫(宝船生物医药科技（上海）有限公司，中国)

摘要

目的：建立抗CSF-1R抗体（BC006）生物学活性的报告基因测定方法。方法：构建CSF-1R/SRE-luc-CHO-K1转基因细胞株作为靶细胞，建立和优化BC006生物学活性检测方法并进行方法学验证。结果：报告基因法优化后确定靶细胞铺板密度为5×104 个·孔-1，抗体起始浓度为200 μg·mL-1，诱导时间6 h。方法验证结果说明该方法具有良好的专属性，进行准确性、精密度和线性验证，结果显示生物学活性回收率在95.3%~102.1%，GCV均小于12%，相对偏差（RB）在-7.7%~10.3%，相对效价理论值与实测值直线回归分析相关系数为0.9998。结论：本研究成功建立了BC006生物学活性的报告基因检测方法，该方法具有较高的准确性和精密度，且特异性良好，可作为此类抗体活性评价的常规方法。

关键词

抗CSF-1R抗体；BC006；生物学活性；报告基因

参考

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DOI: http://dx.doi.org/10.12345/yzlcyxzz.v8i2.24009