Production of rabies vaccine by an industrial scale BHK 21 suspension cell culture process.

A process for the production of an inactivated rabies vaccine for animal use is described, whereby the LEP Flury strain of rabies virus is grown in 1 000 L cultures of BHK 21 suspension-adapted cells. The virus is inactivated with aziridine and, after concentration and purification by hollow fibre ultrafiltration, is adsorbed onto aluminum hydroxide gel. The BHK 21 suspension-adapted Master Cell Seed used has satisfied all the requirements of the US Code of Federal Regulations, Title 9, (1977) for cell lines. Cultures prepared from it produce high yields of rabies virus antigen and vaccines with an average potency of 6 IU can be produced without difficulty. Such vaccines give at least 3 years' protection in dogs and are safe to use in all species. Experience gained with the closely analogous process for the production of FMD vaccines suggests that the process can be readily transposed and successfully operated in developing countries if and when it becomes cost-effective to do so.