Engineered T-cell therapies, specifically CAR-T cell therapies, have emerged as a breakthrough treatment for several blood cancers including diffuse large B-cell lymphoma (DLBCL), B-cell acute lymphoblastic leukemia (B-ALL), mantle cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia and multiple myeloma (1). CAR (chimeric antigen receptor) T-cell therapy involves collecting T cells from a patient and re-engineering them to detect and destroy cancer cells.
While these therapies have improved progression-free and overall survival in many cases, their complex manufacturing workflows and rapid expansion into new cancer types have introduced a demand for quality control, identity testing and process traceability (1).
