Santa Monica-based Kite, which makes immunotherapy drugs that target cancers has announced that the U.S. Food and Drug Administration certified ready for commercial production the company’s fourth manufacturing facility – this one in Oceanside.
Kite, which is a subsidiary of Foster City-based pharmaceutical giant Gilead Co., already has manufacturing plants in El Segundo, Frederick, Maryland and Amsterdam in the Netherlands.
Those plants all make Kite’s signature product, chimeric antigen receptor and T-cell receptor (or CAR T-cell) engineered cell therapies used to treat certain blood cancers and solid tumors. The goal is to engineer T-cells, also known as immune cells, to boost the body’s defenses against these cancers.
But this new plant in Oceanside, which has been ramping up operations over the past year in advance of the FDA decision, is focused only on making viral vectors, which are a key component of these CAR T-cell therapies. Once a therapy is created, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient.
Prior to the FDA approval, Kite could use the viral vector products made at the Oceanside plant for internal research purposes only. The FDA approval now allows the viral vectors to be used in commercial CAR T-cell therapies to treat patients.
“The FDA approval of our commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow,” said Christi Shaw, the chief executive officer of Kite.