Freeze-Dried Rabies Vaccine For Human Use

Rabies vaccine is a freeze-dried preparation made from the inactivated rabies fixed virus. The virus grows in vero cells. After cultivation, harvest and concentration, the virus suspension is inactivated, purified and then lyophilized to make the vaccine after the addition of a suitable stabilizer. It is used to prevent rabies.1 basic requirementsthe facilities, source and subsidiary materials,water. Apparatus and animals used for production and control tests shall comply with the requirements set forth in the general notices.2 manufacturing2. 1 cell substrates for vaccine production vero cells shall be used for the vaccine production2. 1. 1 management and control tests on cell substrates.it complies with the requirements for preparation and control of animals cell substrates used for production of biologics. The maximum passage number of the cells from cell banks at every level shall not exceed the approved limit.2. 1. 2 cell substrate preparationthe cells from one or more containers of the working cell bank are resurrected to expand by serialsubculture up to a quantity enough for making one lot of vaccine. The quantity of the cells can bedefined as a cell batch. During the subculture of the cells, trypsin or other suitable digestion solution at an appropriate concentration is added onto the monolayer cell cultures to disperse cells. The dispersed cells are suspended evenly with suitable growth medium and distributed into culture bottles. Incubate the cells at 370c to form c