Bulk Of Rabies Vaccine For Human Use

Ready to fill bulk [Standard for implementation]Pharmacopoeia of the People's Republic of China Vol. 3, 2015 and the official standard of this product registration.[Manufacturing] 2. 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 confluent monolayers.2. 2   Virus seeds2. 2. 1   Name and origin of virus strainsRabies fixed virus CTN-1V strain and aGV strain or other approved Vero cell-adapted rabies fixedvirus strain can be used as the seed for the vaccine production.2. 2. 2   Establishment of virus seed lot systemIt complies