Autologous CAR-T cell therapy is a type of adoptive cell therapy in which T-cells from a patient’s own immune system are modified in a laboratory before being returned to the patient’s body. The T-cells collected at the start are then grown in large numbers after the modification is complete. These defenders of the human body return as an upgraded, specialized force, newly equipped with Chimeric Antigen Receptors (CAR). Termed CAR-T cells, these cells and their new receptor proteins can detect antigen molecules on enemies like cancer cells to destroy them. CAR-T cell therapies hold tremendous promise for some patients whose cancer is failing to respond to other treatments, but the process of manufacturing CAR-T cells is challenging and complex. If the cell editing process creates unanticipated changes in the T-cells and they are then introduced into the patient’s body, the cells might not behave as expected. This represents an unacceptable risk for individuals whose health is already fragile. It is essential that state-of-the-art quality control tools and methods be employed in CAR-T cell manufacturing to screen for those unintended cell modifications. KromaTiD’s directional Genomic Hybridization™ (dGH™) is a cutting-edge technology being used to improve upon the current quality control barriers slowing down the growth of the CAR-T cell therapy industry. dGH can detect structural and numerical chromosome abnormalities, as traditional karyotyping and FISH do but at a finer resolution. Additionally, dGH provides DNA strand orientation data that neither FISH, nor G-banded karyotyping offer. Researchers are using dGH in CAR-T cell manufacturing to both confirm quality data from other testing methods, and to generate data those methods can’t produce.1 CAR-T cell therapies may soon become part of the standard of care for certain cancers, but only once the right tools are in place to guarantee the stringent quality control standards necessary to obtain government approval.


Madison BB, Patil D, Richter M, Li X, Tong M, Cranert S, et al. Cas-CLOVER is a novel high-fidelity nuclease for safe and robust generation of TSCM-enriched allogeneic CAR-T cells. Mol Ther Nucleic Acids (2022) 29:979–95. doi: 10.1016/j.omtn.2022.06.003