To date, the U.S. Food and Drug Administration has approved three chimeric antigen receptor T cell (CAR T) immunotherapies for B-cell cancers: axicabtagene ciloleucel (Yescarta), for lymphoma, in 2017; tisagenlecleucel (Kymriah), for leukemia and lymphoma, in 2018; and lisocabtagene maraleucel (Breyanzi), for lymphoma, in 2021.
Those approvals mark strides in cancer and immunotherapy research, but there's still a lot to learn, says Alejandro Montoya, M.Sc., a senior product line manager at Corning Life Sciences.
"CAR T cells have opened a new era in cancer immunotherapy," Montoya says. "But we're still in the infancy of this breakthrough technology. CAR Ts are being improved and enhanced to make them more robust, controllable, effective, and accessible — such as the ability to recognize more than one antigen at one time."
Despite the ongoing improvements in CAR T science, barriers in manufacturing and scale create new limitations. The cancer immunotherapy supply chain is delicate. It's reliant on apheresis (the extraction, isolation, and reinfusion of cells) but there's always a time crunch — namely, how fast a cancer is spreading.
"During the time between when a clinician draws a patient's blood and reinfuses it back as treatment, the disease can progress rapidly," says Ben Josey, Ph.D., a field application scientist at Corning Life Sciences. "And in the case of cancer, it can change. The faster you can get these treatments back to the patient, the higher the likelihood that it's going to be effective."
But the workflows are largely manual and time intensive. Lymphocyte isolation, for example, requires adding density gradient media — and it's not fully understood what effects, if any, that process has on cell phenotype. And samples need multiple rounds of centrifuging and washing. These tasks eat up lab resources, and they introduce the risk of human error.