细胞工厂制备冻干甲型肝炎减毒活疫苗的研究

[目的]采用细胞工厂代替传统转瓶培养人胚肺二倍体细胞（2BS细胞），制备冻干甲型肝炎减毒活疫苗，扩大产量。[方法]2007年10月采用传统转瓶、2层、10层和40层的细胞工厂培养2BS细胞，比较相同细胞在接种相同占地面积、不同培养容器上的生长情况，感染甲型肝炎病毒L—A-1株减毒株，按照现行版《中国药典》制备甲型肝炎病毒原液、半成品和成品，并通过各项检定进行比较。[结果]细胞工厂可以有效提高产量3倍以上，细胞生长情况和病毒免疫荧光强度均较好。传统转瓶和细胞工厂不同规格的培养容器制备的病毒原液、半成品和成品经检定，各项指标均符合标准。[结论]采用细胞工厂制备冻干甲型肝炎减毒活疫苗，在有限培养空间内，具有提高产量、简化操作、降低污染、降低人员劳动强度等优点，可代替传统转瓶规模化生产冻干甲型肝炎减毒活疫苗。

Preparation of Hepatitis A （Live） Vaccine,Freeze-dried with Cell Factory

[Objective]Instead of culturing human fetal lung diploid cell （2BS ceils） with traditional roller bottle, cell factory will expand the production of Hepatitis A （Live） Vaccine, Freeze-dried. [Methods] 2BS cells were cultured with traditional roller bottle cell factory （layer 2,layer 10 and layer 40）, compared the growth of the same cells in the same area of vaccination on different way of culture and container,infected with hepatitis A virus LA-1 strain, then prepared bulk Hepatitis A （Live） Vaccine,semi-finished and finished products in accordance with the current edition of ＂ Pharmacopoeia of Peoples Republic of China＂. [Results]Cell factory could effectively improve the production more than three times, the growth of cell and intensity of immune fluorescence of viral was better. The indicators in test of both traditional roller bot- tle and cell factory were in line with the standard. [Conclusion]The preparation of Hepatitis A （Live） Vaccine, Freeze- dried with Cell factory on finite culture space will increase production, streamline operations, reduce pollution, reduce labor intensity,etc. It can replace the production of Hepatitis A （Live） Vaccine,Freeze-dried with traditional roller bottle.