Kite Pharma opens cell therapy plant as lead CAR-T candidate gathers steam
- Kite Pharma on Monday opened a new commercial manufacturing facility in El Segundo, California, aiming to ramp up production of T-cell therapies for clinical trials and potentially support the commercial launch of its lead candidate, KTE-C19.
- Kite expects the 43,500 square-foot site will be operational by the end of the year to produce therapies for clinical use. The facility is capable of producing up to 5,000 patient therapies per year, the company said.
- KTE-C19 is intended for treatment of diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma. Kite hopes to commercially launch the therapy for this indication in 2017, and is currently in development for other B-cell malignancies.
Kite is moving quickly to ramp up its production capacity in parallel with its development work on KTE-C19. Construction began only a little more than a year ago—in February, 2015.
"Establishing world-class manufacturing capability has always been a priority for Kite," said Timothy Moore, executive vice president of Technical Operations at Kite.
The El Segundo facility is strategically located adjacent to the Los Angeles International Airport to facilitate the receiving and shipping of T-cells from and to patients in the U.S. and Europe. As Kite has focused on autologous T-cell therapies, patients must have their T-cells extracted before Kite genetically enhances them to target cancer cells.
Moore said its manufacturing supply chain will enable Kite to turn a T-cell therapy around in 14 days from receipt of a patient's materials.
Kite currently has an operating clinical manufacturing facility in Santa Monica, California which is currently producing T-cell therapies for development work.
The new facility will need to be approved by the FDA before Kite can use it in clinical or commercial production.