Gilead Company’s subsidiary Kite has received the US Food and Drug Administration (FDA) approval for the commercial production at its new CAR T-cell therapy manufacturing facility in Maryland.
Located in Frederick, Maryland, the 275,000ft2 facility will produce the FDA-approved CAR T-cell therapy which is utilised for the treatment of blood cancer.
The CAR T-cell therapies are manufactured individually for each patient using their own T-cells that are extracted from their white blood cells.
The T-cells of the patient will be sent to the company’s manufacturing facilities and modified with a Chimeric Antigen Receptor (CAR) to recognise, attack, and destroy cancer cells.
The cells will be preserved, packed and sent back carefully to the hospital after the individualised therapy is created for a patient.
This therapy is then infused into the patient to treat blood cancer.
The company stated that the CAR T-cell therapy is a one-time treatment, which is available at authorised treatment centres (ATCs), or hospitals that have CAR T-cell therapy experience.
Kite CEO Christi Shaw said: “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.
“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.”
The company estimated that its global CAR T-cell therapy manufacturing network capacity will be increased by 50% to meet patient demand for new cancer therapies.
Furthermore, the Maryland site also has unfinished space to add capacity in future for accommodating new scientific and technological advances in the cell therapy field.