高致病性猪繁殖与呼吸综合征活疫苗(TJM-F92株)微载体悬浮培养疫苗比较研究

Comparative study on microcarrier-based suspension culture of highly pathogenic porcine reproductive and respiratory syndrome live vaccine(strain TJM-F92)

为了改进高致病性猪繁殖与呼吸综合征(HP-PRRS)疫苗培养工艺,对HP-PRRSV微载体悬浮培养(TJM-F92株)活疫苗的抗原生产工艺、疫苗的安全性及免疫效力等方面进行研究,并与转瓶培养工艺进行比较。结果表明:微载体悬浮培养工艺生产HP-PRRSV(TJM-F92株)优于转瓶培养工艺,其病毒含量比转瓶培养工艺高约10倍,且批间差异小;HP-PRRSV微载体悬浮工艺活疫苗(TJM-F92株)安全性与转瓶培养工艺活疫苗相比无显著差异,均安全;4批活疫苗细菌、支原体、外源病毒检测合格,病毒含量、真空度和剩余水分均符合标准,但免疫效力明显优于转瓶培养工艺活疫苗。说明从疫苗工业化生产及产品质量控制方面来衡量,微载体悬浮培养工艺比转瓶培养工艺更具有优势。

In order to improve the culture process of highly pathogenic porcine reproductive and respiratory syndrome(HP-PRRS) vaccine, the antigen production process, safety and immune efficacy of HP-PRRSV vaccine(strain TJM-F92) cultivated by microcarrier-based suspension were investigated in this study, which were compared with the roller bottles culture process. Results showed that the production of HP-PRRSV vaccine(strain TJM-F92) cultivated by microcarrier-based suspension surpassed that cultivated by roller bottle culture. The viral levels were 10 times higher than the latter, and the difference among batches were smaller as well. There were no significant differences of the safety of HP-PRRSV vaccine between microcarrier suspension culture and roller botttles culture, both methods were safe. The vaccine asepsis, mycoplasma, exogenous virus, virus content, vacuum degree, and residual water were all qualified,but the immunological efficacy of the vaccine produced by microcarrier suspension culture was obviously superior to that produced by roller bottles process. It is indicates that microcarrier suspension culture process has more advantages than roller bottles process, in view of the industrial production and product quality control.