Gilead's Kite Receives FDA Approval For Yescarta Manufacturing Process Change

(RTTNews) - Tuesday, Gilead Sciences, Inc. (GILD) announced that its subsidiary Kite Pharma's Yescarta has received approval from the FDA for a manufacturing process change that will reduce the median turnaround time or TAT for the therapy in the U.S. from 16 days to 14 days.

The median TAT is the time from leukapheresis, when a patient's T cells are collected to product release. After the T-cells are collected through leukapheresis, they are sent to Kite's specialized manufacturing facilities to be modified with a Chimeric Antigen Receptor. Once the individual therapy is prepared, the cells undergo thorough checks, preservation, and packaging before being returned to the hospital for infusion back into the patient.

The manufacturing process from leukapheresis to the delivery of the final product is continuous, making the timing and scheduling critical to the supply.