With an FDA approval for its pricey CAR-T therapy Yescarta under its belt and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt for a new manufacturing site to fuel those hopes. The company found it in Maryland.
Kite said Wednesday that it was building a 279,000-square-foot facility on 20 acres in Frederick County, roughly 20 miles west of Baltimore. The site will employ 400 and 800 workers and expand Kite’s ability to manufacture its next-gen oncology treatments, including Yescarta and its prospective T-cell receptor therapies, the company said.
Tim Moore, Kite’s VP of Technical Operations, said the new facility would step up the company's ability to turn around CAR-T therapies, which require personalized manufacturing.
“This new facility in Frederick County builds on our substantial technical capabilities and rapid progress in making personalized CAR-T and TCR cell therapies for people with cancer,” Moore said in a release, adding that "expanding and investing in our manufacturing capabilities is essential” as Kite works to expand in the nascent field.
Matthew Doyle, a business development specialist with the Frederick County Office of Economic Development, told FiercePharma the facility broke ground in Fall 2018 and will include office and lab space. To support the project, the county gave Kite a $2 million conditional loan, a $200,000 training grant and a suite of state and local tax credits.
The company didn't say how much it would spend to develop the site or when it's planning to start production there.
Kite’s new facility will aid a costly CAR-T therapy manufacturing process that genetically codes a patient’s T cells. Blood must be taken from a patient, cryopreserved, shipped to a manufacturing facility, reprogrammed and manufactured in the lab, and then shipped back for infusion into the patient, all in the shortest time possible.
Kite won FDA approval in October 2017 for Yescarta, a $373,000 one-time treatment for diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma. Yescarta’s sole challenger in the field, Novartis’ Kymriah, lists for $475,000.
In August, Novartis said it would invest $91.5 million over three years to build its own CAR-T manufacturing facility in Switzerland that will employ 450 workers. Novartis struggled in 2018 as manufacturing issues led to doses of Kymriah not meeting specifications and hampered the drug's sales.
That move closely followed Kite’s May announcement that it was building a separate CAR-T manufacturing facility at an Amsterdam airport, a move that would help shorten shipping times.
That 117,000-square-foot facility is expected to employ around 300 workers when it's fully operational in 2020. As with the Frederick County plant, Gilead did not disclose how much it would spend on that facility.
In May, Kite also said it had acquired a new building in Santa Monica, California, from Astellas Pharma that it will use for clinical manufacturing and cell therapy R&D.
The company also picked up a 26,000-square foot facility in Gaithersburg, Maryland, as part of an agreement with the National Cancer Institute to develop adaptive cell therapies targeting patient-specific tumor neoantigens, or mutations found on the surface of cancer cells.
Editor's note: This story was updated to correct the list price for Yescarta. It is $373,000, not $375,000.