细胞工厂培养箱在水痘疫苗生产中的应用研究  

Application of cell factory incubator in varicella vaccine production

作　　者：毛树宝 程庆[1] 陈越[2] 王亮[2] 谢蕾[2] Mao Shubao Cheng Qing Chen Yue Wang Liang Xie Lei(Production Department, Shanghai Institute of Biological Products Co., Ltd., Shanghai 200051, China)

机构地区：[1]上海生物制品研究所有限责任公司生产部,200051 [2]上海生物制品研究所有限责任公司生物技术制品中心,200051

出　　处：《国际生物制品学杂志》2016年第6期281-284,共4页International Journal of Biologicals

摘　　要：目的 应用细胞工厂培养箱在水痘疫苗生产过程中进行细胞培养和病毒培养,以提高病毒滴度,减少批间差异.方法 采用细胞工厂培养箱对MRC-5细胞和水痘病毒Oka株进行培养,以传统孵房培养为对照,比较两种方式的细胞生长和病毒感染情况,以及原液病毒滴度和半成品得率.采用t检验对结果进行比较.结果 在同批次同量细胞复苏的情况下,细胞工厂培养箱培养的细胞和病毒与传统孵房培养相比,分布更密集、更均匀,且批间差异较小.细胞工厂培养箱培养得到的水痘病毒滴度为5.1～5.2 lg噬斑形成单位（plaque-forming unit,PFU）/ml,高于传统孵房培养病毒（4.9～5.1 lgPFU/ml）（t=-3.17,P＜0.05）;前者培养制备的半成品得率也高于后者,分别为100％和76％～100％（t=-2.69,P＜0.05）.结论 在水痘疫苗生产过程中应用细胞工厂培养箱,能够提高病毒滴度和批间均一性,适合水痘疫苗的大规模生产.Objective To increase varicella virus titer and reduce batch difference by cultivation of cells and virus in cell factory incubator during vaccine production.Methods MRC-5 cells and Oka strain varicella virus were cultured in cell factory incubators and traditional hatch room.The status of cell growth and virus infection were observed.The virus titer of bulk and yield rate of final bulk were determined.The results from the above two culture modes were compared with t-test.Results When the same batch and number of cells were recovered,the cells and virus cultured in cell factory incubator distributed more densely and uniformly compared with those in traditional hatch room.Also,less batch difference was found when the incubator was used.The titer of virus cultured in cell factory incubator was higher than that in traditional hatch room,5.1-5.2 lg plaque-forming unit （PFU）/ml vs 4.9-5.1 lgPFU/ml （t=-3.17,P 〈0.05）.The yield rate of final bulk produced from cell factory incubator was also higher than that from traditional hatch room （100% vs 76%-100%;t=-2.69,P 〈0.05）.Conclusions The cell factory incubator used in varicella vaccine production can improve virus titer and batch uniformity.It is suitable for large-scale production of varicella vaccine.

关 键 词：细胞培养技术 水痘疫苗 病毒滴度 

分 类 号：R392-33[医药卫生—免疫学]