FDA approves Kite’s CAR T-cell therapy manufacturing facility in Maryland

The U.S. Food and Drug Administration (FDA) approved Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland, the company announced.

Kite, a Gilead Company, is a member of the Biotechnology Innovation Organization (BIO).

The state-of-the-art, 275,000-square-foot facility will produce the FDA-approved CAR T-cell therapy used to treat blood cancer. More than 400 people are expected to work at the facility by the end of 2022.

Kite already has manufacturing facilities in El Segundo, California, and Amsterdam, Netherlands. The new facility will increase manufacturing capacity by 50%, according to Kite.

“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 and a member of the Executive Committee of the BIO Board of Directors.

What is CAR T-cell therapy?

“CAR T-cell therapies are individually manufactured for each patient using their own T-cells extracted from their white blood cells” explains Kite. “The patient’s T-cells are sent to Kite’s manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR) to recognize, attack and destroy their cancer cells. Once the individualized therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient.”

Unlike other treatments, it’s typically a one-time treatment.

Watch Kite’s Christi Shaw explain what advice she would give to her younger self:

Want to know more about the future of CAR T-cell therapy? Read how new bioimplants can speed production of CAR T-cells that attack tumors.

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