CAR T-Cell Therapy Manufacturer Plans to Cut Production Time

The production of chimeric antigen receptor (CAR) T-cell therapies typically takes 2 weeks, but Juno Therapeutics, a major producer of the therapies, hopes to reduce production time to 2 days using technology from a newly acquired company.

Juno Therapeutics plans to introduce automated manufacturing, cell selection, and activation capabilities to accelerate its existing cellular therapy production process. The new system would involve two parts, an automated instrument and novel re-agents that work specifically with that instrument, according to the manufacturer.

Manufacturing CAR T cells is a labor-intensive process with a high possibility of failure. Companies are interested in accelerating the production rate for commercial use, which will require a process that creates a safe, clinically effective cell product that is replicable throughout the life cycle of the cell.

Though they continue to show promise for the treatment of hematologic malignancies, CAR T-cell therapies have faced recent setbacks over safety concerns. In March, the U.S. Food and Drug Administration (FDA) granted priority review to CTL019, an investigational CAR T-cell therapy for the treatment of relapsed/refractory B-cell acute lymphocytic leukemia in pediatric and young adult patients. But earlier in the month, Juno Therapeutics announced that it was halting development of its JCAR015 therapy following several patient deaths from cerebral edema and a clinical hold from the FDA.

Source: Juno Therapeutics press release, May 5, 2017.