Gilead’s Kite receives US FDA ok for Maryland CAR-T plant

The 20-acre site in Frederick, Maryland will produce CAR-T therapy Yescarta and increase its network capacity by 50%, says Kite.

In 2018, Gilead Sciences, fresh from its $11.9 billion acquisition of Kite Pharma, announced plans to expand its manufacturing network with a 275,000 square foot facility in Frederick County, Marland to produce chimeric antigen receptor (CAR) T-cell therapies.

Now, the firm has received approval from the US Food and Drug Administration (FDA) to manufacture CAR-T cell therapy Yescarta (axicabtagene ciloleucel), which was granted authorization in 2017 and is used to treat blood cancer.

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“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.

She continued: “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.”

Kite began constructing the facility in 2019 and the firm claims the site has been built using knowledge taken from its manufacturing network, as well as automation for some previously manual processes.

Furthermore, the Maryland plant has “unfinished space” to add future capacity, which will allow the company to house potential technological and scientific discoveries in the cell therapy industry and meet demand.

Kite expects to have over 400 employees working at the site by the end of this year and is dedicated to training the region’s cell therapy talent through various partnerships with government organizations and academic institutions.

The Maryland site joins Kite’s other manufacturing facilities in Southern California and Amsterdam, Netherlands, which received approval from the European Medicines Agency (EMA) in June 2020. The firm claims it has formed the largest in-house cell therapy manufacturing network in the world.