Cell Therapy Clinical Activity and Process Automation

Cell therapy has emerged as a promising new approach to treat malignancies that could only be treated on a palliative basis. Among those therapies, chimeric antigen receptor (CAR) modified T cell therapies has proved to be effective for hematological malignancies. To generate CAR T cells, patient- (autologous) or donor-derived (allogeneic) T cells are modified to express a CAR. The CAR is a chimeric construct containing at least one signaling domain of the T cell receptor and a single chain variable fragment (scFv).

The production of autologous CAR T cells is carried out by a variety of manufacturing approaches all comprising the same common steps. First, the patient’s white blood cells (WBCs) are isolated by leukapheresis and washed. Then, the T cells are activated, transduced with the CAR transgene, expanded to the required cell numbers for therapy, formulated and filled. After quality control testing and preparatory lymphodepleting chemotherapy for the patient, the product is injected into the patient.