不同生产工艺制备水痘减毒活疫苗(VZV 84-7株)的比较  

Live attenuated varicella vaccines(VZV 84-7 strain)prepared by various processes

作　　者：李立[1] 侯良玉[1] 麻广[1] 丁秀红[1] 李永忠[1] 哈秀杰[1] 曾昊[1] 李毅[1] 邹蔚然[1] 林崇建[1] 单玉杰 刘晔[1] 黄林[1] 

机构地区：[1]成都生物制品研究所有限责任公司病毒性疫苗二室,四川成都610023

出　　处：《中国生物制品学杂志》2015年第2期177-181,共5页Chinese Journal of Biologicals

摘　　要：目的采用细胞工厂替代传统转瓶工艺制备水痘减毒活疫苗(VZV 84-7株)。方法分别用细胞工厂和3 L转瓶培养2BS细胞,制备水痘减毒活疫苗(VZV 84-7株)各6批,采用Countstar全自动细胞计数仪进行细胞计数,并以计数结果中的单位面积细胞数、成活率及消化后细胞的平均直径为指标,考察细胞质量,同时采用蚀斑法检测原液、成品及成品37℃放置7 d后(热稳定性)的病毒滴度。结果采用细胞工厂连续制备的6批2BS细胞的平均单位面积细胞数、细胞平均成活率均略优于3 L转瓶培养工艺,平均直径变动范围小于3 L转瓶;细胞工厂制备的6批疫苗,平均原液滴度为5.58 lg PFU/ml,平均成品滴度为4.78 lg PFU/0.5ml,37℃放置7 d后的平均病毒滴度为4.13 lg PFU/0.5ml,优于3 L转瓶。结论利用细胞工厂制备水痘减毒活疫苗(VZV 84-7株),可获得更高滴度病毒液,降低疫苗生产过程中的劳动强度及污染风险,并提高了疫苗产量及质量的稳定性,适合于水痘减毒活疫苗(VZV 84-7株)的规模化生产。Objective To prepare live attenuated varicella vaccines（VZV 84-7 strain）by cell factory instead of traditional roller system. Methods Six batches of 2BS cells were cultured in cell factory and 3 L roller separately,and counted by fully automatic Countstar cell counter,based on which the cell quality was evaluated by the cell count in unit area,survival rate and mean cell diameter after digestion. Meanwhile,the heat stability of vaccines were evaluated by determination of virus titers in bulk,final bulk and final product after storage at 37 ℃ for 7 d by plaque assay. Results The mean count in unit area and mean survival rate of six batches of cells prepared by cell factory were slightly higher,while the change range of mean diameter was less than those by culture in 3 L roller. The mean titers of bulk and final product of six batches of vaccine prepared by cell factory were 5. 58 and 4. 78 lg PFU / 0. 5 ml respectively,while the mean titer of final product after storage at 37 ℃ for 7 d was 4. 13 lg PFU / 0. 5 ml,which were higher than those culture in 3 L roller. Conclusion The titer,yield and stability of live attenuated varicella vaccines（VZV 84-7 strain）prepared by cell factory increased,while the intensity of labor and risk of contamination during production decreased,indicating that cell factory was suitable for large-scale production of live attenuated varicella vaccine（VZV 84-7 strain）.

关 键 词：细胞工厂 人二倍体细胞(2BS株) 水痘减毒活疫苗 

分 类 号：R373.12[医药卫生—病原生物学] R392-33[医药卫生—基础医学]