In order to produce consistent biological products, it is essential to maintain a uniform and undamaged cell population. Creating a cell bank system also guarantees that there is an adequate supply of material available for the generation of cell lines expressing recombinant proteins or monoclonal antibodies.
The creation of therapeutic products depends on a master cell bank (MCB), which facilitates clinical research, production, and the commercial supply stage of biological products. When developing an MCB, a lot of things can go wrong. A few potential problem sources include genetic variation, cell line contamination, and the use of incorrect and uncharacterized cell lines. These cell banks need to be thoroughly examined and checked for impurities like fungi, bacteria, and mycoplasmas before being submitted for regulatory approval.
