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[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。
[Objective] The purpose of this study was to replace the traditional roller bottle culture of human embryo lung diploid cells (2BS cells) with a cell factory to prepare a live attenuated attenuated hepatitis A vaccine and expand the production. [Method] In October 2007, 2BS cells were cultured in traditional cell rearing bottles, two-storied, ten-storied and forty-storied cell factories. The growth of the same cells on the same area and in different culture containers was compared, and the hepatitis A virus LA-1 strain attenuated strain, according to the current version of “Chinese Pharmacopoeia” preparation of hepatitis A virus stock solution, semi-finished products and finished products, and through the test for comparison. [Result] The cell factory could effectively increase the yield more than 3 times, and the cell growth and virus immunofluorescence intensity were better. Traditional bottle and cell factory culture containers of different specifications prepared virus stock solution, semi-finished products and finished products were tested, the indicators are in line with the standards. [Conclusion] The use of cell factory to prepare freeze-dried hepatitis A attenuated live vaccine can increase the yield, simplify the operation, reduce the pollution and reduce the labor intensity in the limited cultivation space. It can replace the traditional freeze-drying Hepatitis A live attenuated vaccine.