When it comes to producing more consistent biological products, having a proper cell bank is vital. These systems have been set up to ensure that there is a uniform population of cells that has been preserved, maintaining its integrity.
There is also a need for a sufficient supply of material that will be accessible over the course of the product’s life. This is where biosafety testing on those cell lines throughout multiple passages would be necessary. There is a lot that goes into creating a working cell bank, and working with the right service is crucial.
Biosafety Testing
In the generation of a working cell bank, biosafety testing is in place to ensure a few things. One is a homogenous cell bank as well as screenings for both contaminations and mutations.
Testing will include a few things as well. This includes things such as contamination testing for fungi, mycoplasma, or virus, sterility and PCR testing for viruses, DNA sequence verification and fingerprinting of vector constructs, and more.
Working Cell Banks
A working cell bank is necessary, particularly in the later stages of not only development but also manufacturing of cells that may be potentially therapeutic. They are typically produced through the expansion of a single vial of a master cell bank which has been characterized for viability and has been through the passage process several times.
Depending on your needs, there may be mammalian cells, insect cells, or rodent cells available in short order.