Gilead Plans New Mfg Facility for Cell Therapies

Kite, part of Gilead Sciences, has announced plans for a new facility in Frederick County, Maryland, which will produce cell therapies for treating cancer. The 20-acre site will expand Kite’s ability to manufacture a variety of chimeric antigen receptor T (CAR T) therapies, including Yescarta (axicabtagene ciloleucel), Kite’s first commercially available CAR T cancer therapy, and investigational T cell receptor (TCR) cell therapies being evaluated in solid tumors.

Yescarta, a CAR T cell therapy, involves (1) harvesting T cells from the patient’s blood, (2) engineering T cells to express cancer-specific receptors, (3) increasing the number of engineered T cells and (4) infusing the functional cancer-specific T cells back into the patient. The company uses its El Segundo, California facility for the clinical and commercial manufacture and processing of Yescarta on a patient-by-patient basis, according to the company’s annual report.

The Frederick County facility will become part of Kite’s commercial manufacturing network that includes sites in California and the Netherlands.

Following its $11.9-billion acquisition of Kite Pharma in 2017, Gilead announced in 2018 that it had leased and purchased new facilities in the US and Europe to expand its cell-therapy manufacturing capabilities. Kite leased a new 117,000-square-foot site facility in Hoofddorp, the Netherlands to engineer cell therapies, including for Yescarta. The new facility is scheduled to be fully operational in 2020. In addition to the Netherlands facility, Kite purchased a new building in Santa Monica, California from Astellas Pharma that will be used for cell-therapy research, development, and the expansion of clinical manufacturing capabilities. Kite also leased a 26,000-square-foot facility in Gaithersburg, Maryland. The Maryland site will support the work of a Cooperative Research and Development Agreement with the National Cancer Institute to develop adoptive cell therapies targeting patient-specific tumor neoantigens. Neoantigens are mutations found on the surface of cancer cells that are unique to each person and tumor.

Source: Gilead Sciences

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