FDA Approves Kite’s CAR T-Cell Therapy Manufacturing Facility in Maryland

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FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Kite, a Gilead Company, announced on April 19, 2022 that FDA has approved commercial production at the company’s new chimeric antigen receptor (CAR) T-cell therapy manufacturing facility in Frederick, Md. Kite will use the facility to product its CAR T-cell therapy used to treat blood cancer.

The new facility will add to Kite’s existing manufacturing sites in Southern California and Amsterdam, Netherlands. According to the company, the expansion will form the largest dedicated in-house cell therapy manufacturing network in the world. Kite anticipates network capacity to increase by 50%.

CAR T-cell therapies are manufactured individually for each patient, using the patient’s own T-cells extracted from their white blood cells. The T-cells are then modified at the site with a chimeric antigen receptor to recognize, attack, and destroy their cancer cells. The therapy is then transferred back to the hospital to be infused back into the patient. It is a one-time treatment, unlike most other cancer treatments currently available.


“The FDA approval of our Maryland site marks an important milestone within our global CAR T-cell therapy manufacturing network, and will enable us to significantly expand our production capacity and further strengthen our ability to meet the needs of people living with difficult-to-treat blood cancers,” said Christi Shaw, CEO of Kite, in a press release. “Manufacturing is central to every decision we make at Kite. Our teams hold patients’ cells in their hands every day, which could mean the difference between getting a chance to live or possibly losing their battle with cancer. It must be fast and extremely high quality to give patients the best outcome.”

Source: Kite