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Kite’s new CAR T-cell therapy manufacturing facility given the go-ahead by the FDA

The site in the US will produce CAR T-cell therapies for patients with blood cancers


Kite, a Gilead Company, has announced that the US Food and Drug Administration (FDA) has approved the launch of commercial production at its new CAR T-cell therapy manufacturing facility.

The site, situated in the US, is set to produce Kite’s FDA-approved CAR T-cell therapy used to treat blood cancers.

The site adds to Kite’s existing manufacturing facilities in the US and the Netherlands, forming the largest, dedicated in-house cell therapy manufacturing network in the world.

It covers process development, clinical trial production, vector manufacturing and commercial product manufacturing.

Following the FDA’s commercial production approval, Kite has estimated that its network capacity will be increased by 50%, allowing further patients to be assessed now and in the future.

“The FDA approval of our 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.

She added: “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.”

CAR T-cell therapy is unlike other cancer treatments as it is a one-time treatment. The therapies are individually made for each patient, using their own T-cells extracted from their white blood cells. The process involves sending the patient’s T-cells to Kite’s manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR) to identify and destroy their cancer cells.

The company started building the facility in 2019 and, although the site has unfinished space, it has allowed for future capacity which will be available to accommodate potential new scientific advances in cell therapy.

Article by
Fleur Jeffries

21st April 2022

From: Regulatory



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