摘要目的 通过检测冻干乙型脑炎灭活疫苗(Vero细胞)生产过程各道工序中的细胞残余蛋白,达到控制疫苗中Vero细胞残余蛋白的目的.方法 采用Vero细胞宿主细胞蛋白(host cell protein,HCP)试剂盒,对2009-2012年共65批冻干乙型脑炎灭活疫苗(Vero细胞)在病毒液收获、浓缩、硫酸鱼精蛋白处理、纯化、脱糖和半成品配制阶段中的HCP含量进行检测.结果 2009-2012年,病毒液收获阶段Vero细胞HCP含量无明显差异.2010年工艺优化后,2010-2012年的HCP平均值与2009年相比,在浓缩、硫酸鱼精蛋白处理、纯化、脱糖、半成品配制阶段分别降低了78.83％、83.42％、78.62％、86.88％、86.40％.结论 通过Vero细胞HCP试剂盒的动态监测,可以对生产过程中Vero细胞的残余蛋白含量实施控制.

abstractsObjective To control residual proteins of Vero cell in the inactivated lyophilized Japanese encephalitis vaccine (Vero cell) by determination of the residual protein in each stage of production process.Methods A total of 65 lots of the vaccines produced from 2009 to 2012 were selected.The content of HCP in the process of virus harvesting,concentration,protamine sulfate treatment,purification,desugarization,and final bulk preparation was determined by a diagnostic kit for host cell protein (HCP),respectively.Results There was no obvious difference in HCP content of Vero cell in virus harvests from 2009 to 2012.After process optimization in 2010,the mean HCP values during 2010-2012 in the process of concentration,PS treatment,purification,desugarization,final bulk preparation were decreased by 78.83％,83.42％,78.62％,86.88％,and 86.40％,respectively,as compared with the corresponding values in 2009.Conclusion Dynamic monitoring of residual protein using HCP diagnostic kit has guiding significance for control of HCP content of Vero cell in the manufacturing process.