Vero细胞狂犬疫苗的研制

Study on Vero Cell Rabies Vaccine

利用自建的狂犬病毒Vero细胞适应株和细胞反应器微载体系统培养Vero细胞和狂犬病毒，病毒滴度达到6．0～8．0log(10)LD(50)／ml。病毒原液纯化后制出的纯化狂犬疫苗质量基本上均能达到WHO对此类型疫苗的主要质控要求。表明疫苗小量试制工艺基本可行。

The primary manufactory technique for Vero cell rabies vaccine was established. The quality of the experimental vaccine meet 'the requirment for Vero cell rabies vaccine' introduced byWHO in 1986.The Vero cell strain used for the vaccine production was from ATCC(U. S. A. ). RFD virusstrain used as seed virus for the vaccine was established by our laboratory in 1989.The Vero cell was cultured in X-celligen(5L) with microcarrier and then were infectedwith RFD fixed virus. The supernatant containing rabies virus was harvested at 2~3 days intervals. The virus titer of the supernatants was 6~8 log LD(50)/mL. The virus pool was concentratedby ultrafiltration and the virus components were isolated by chromatograph. The final productcontains human albumin as stabilizer and Al(OH)3 as adjuvant. So, it is an adsorbed purified Verocell rabies vaccine.Six lots of the vaccine were detected by QC group. The results showed that the vaccine is safeand potent. The potency of every lot is ≥2. 5 IU/dose, the residual bovine serum and cell DNAin all of the vaccine are ≤1 μg/mL and ≤100 pg/dose, respectively.