I know it is an chimera of mouse/human antibodies, but are mice used in the production process, or is it a case of the cells that were originally harvested from mice being used indefinitely in vitro?
Basically what I'm asking is was the mouse involvement a one off thing, or are new mice needed to replenish the source constantly?
I'm hoping it's something similar to Henrietta Lack's HeLa cells?
I've been researching this online, but I seem to have reached a dead end.
I can't speak for rituximab specifically but I am familiar with the production methods of monoclonal antibodies and proteins from recombinant DNA ( specifically ones derived from chinese hamster ovary cells ) Most biological drugs are manufactured similarly.
The cells are modified genetically to produce the protein required. Basically then there is a master cell bank from which all batches get made. No further mice or chinese hamsters are involved in the process once a master cell bank is made.
A typical batch starts off in a flask and as the cells multiply it is transferred in to ever increasing sized vessels eventually ending up in a production bioreactor of up to 20,000 litre in some cases.This can take several weeks.
Then the cells need to be discarded and the protein needs to be harvested. Then the protein carrying solution is purified to remove impurities from the host cell. This involves a lot of filtration and chromatography steps. Finally the solution is exchanged with a buffer that is suitable for freezing or lyophilisation or final filling, for eventual injection or infusion.
If you want to know any specifics let me know. I don't know much of the biology or genetics bit I do know the manufacturing side of things.