Application of potency/Identity detection items  

Taking CAR-T cells as an example, identity detection can detect different cell surface markers, including at least two types. One type of surface marker is used to detect non-target cell components of CAR-T cells and limit their proportion, and the other type is used to identify the proportion of target T cells in CAR-T cells and the composition of different T cell phenotypes. 

Similar to other biological products, the potency detection methods of CAR-T cells should preferably simulate the mechanism of action (MOA) of the product, such as external potency detection methods such as killing rates of tumor cells、cell proliferation and inhibition rate and IFN-γ expression quantity after co-incubation of CAR-T cells and tumor target cells in vitro, or other in vivo potency detection methods.