口蹄疫疫苗的悬浮培养工艺研究

Application of Suspension Culture in FMD Vaccine Production

通过生物反应器中进行BHK21细胞悬浮培养并逐级放大,分别接种口蹄疫OJMS/2000株与Asia 1/JSL株,纯化灭活后制备50批疫苗,结果均符合《口蹄疫O型、亚洲I型二价疫苗(OJMS株+JSL株)制造及检验规程》(以下称规程)所规定的各项标准,病毒146S抗原含量比转瓶培养提高10倍以上、疫苗的不良反应得到进一步改善。

BHK21 cells were cultured in bioreactor,and were enlarged step by step.OJMS/2000 strain or Asia 1/JSL strain of FMDV was inoculated into the cells culture.We prepared about 50 batches vaccines of FMD O type and Asia I type bivalent vaccine.Through all kinds of test,the result demonstrated that all vaccines accorded with the request of FMD O type and Asia I type bivalent vaccine（OJMS strain＋JSL strain） production and test standards（It was called standards in the following）.The content of virus 146S antigen was above 10 times of the content produced by roller bottles.Adverse reaction was improved.