目的 探索HEK293报告基因法（reporter gene assay，RGA）检测3个厂家贝伐珠单克隆抗体（单抗）产品的可行性。方法 采用RGA分别检测3个厂家贝伐珠单抗产品的生物学活性，并对该方法的线性、准确度、精密度进行验证，探索胎牛血清浓度、细胞铺板密度、细胞培养代次对RGA检测结果的影响。结果 RGA检测3个厂家贝伐珠单抗产品绘制的四参数曲线显示，厂家-2信噪比高，厂家-2和厂家-3拟合度好；理论相对效价为50%~150%时，相对效价的理论对数值与其效价测定值呈现良好的线性关系；3个厂家产品的回收率均在70%~130%之间，相对标准偏差均＜20%；胎牛血清浓度为5%和10%，细胞铺板密度在0.6×10⁵、0.9×10⁵和1.2×10⁵个/孔，细胞代次8、16、23代时，活性测定拟合曲线较好。结论 RGA能实现对3个厂家贝伐珠单抗产品的生物活性检测，虽然方法的线性、准确度、精密度良好，但胎牛血清浓度、细胞铺板密度及细胞代次对RGA检测结果有一定影响。

Objective To explore the feasibility of detecting bevacizumab products from 3 manufacturers using the HEK293 reporter gene assay (RGA).Methods The biological activities of bevacizumab products from 3 manufacturers were detected by RGA respectively. The linearity, accuracy, and precision of this method were verified, and the effects of fetal bovine serum (FBS) concentration, cell seeding density, and cell culture passage number on RGA detection results were investigated.Results The four-parameter curves plotted for the RGA detection of bevacizumab products from 3 manufacturers showed that manufacturer 2 had a high signal-to-noise ratio, and manufacturer 2 and 3 exhibited high goodness of fit. When the theoretical relative potency ranged from 50% to 150%, the theoretical logarithm of relative potency showed a good linear relationship with the measured potency value. The recovery rates of the products from 3 manufacturers all fell within the range of 70% to 130%, and the relative standard deviations were all less than 20%. When the FBS concentration was 5% or 10%, the cell seeding density was 0.6×10⁵, 0.9×10⁵, or 1.2×10⁵ cells per well, and the cell passage numbers were 8, 16, or 23, the fitting curves of activity determination were all good. Conclusions RGA can be used to detect the biological activities of bevacizumab products from 3 manufacturers. This method has good linearity, accuracy, and precision, but the FBS concentration, cell seeding density, and cell passage number have certain effects on the detection results of RGA.