The US FDA has approved Kite’s retroviral vector manufacturing plant in Oceanside, California for commercial production.
According to Gilead company Kite Pharma, the authorization received from the US Food and Drug Administration (FDA) concerning its retroviral vector (RVV) facility in California supports its worldwide chimeric antigen receptor (CAR) T-cell therapy production network and helps meet demand of the firms’ blood cancer treatments.
“With today’s approval, we’ll begin transitioning viral vector supply to our inhouse Oceanside manufacturing facility, while maintaining our CMO partnerships,” a spokesperson for Kite told us.
“More broadly, the FDA approval further strengthens our global cell therapy manufacturing network with the addition of an inhouse capability to produce a crucial element in the CAR-T process.”
Kite dubs viral vectors as “key components” that are required to produce its cell therapies for specific blood cancers. In 2017, the company’s first CAR-T therapy, Yescarta (axicabtagene ciloleucel) received US FDA approval and, three years later, the firm got its second approval for Tecartus (brexucabtagene autoleucel), a CAR-T cell therapy for the treatment of mantle cell lymphoma (MCL).
Kite claims it is the only cell therapy firm that has inhouse viral vector production capabilities for commercial products as well as clinical trials. Furthermore, the firm says that by having inhouse viral vector capacity and capabilities, it ensures a reliable and continuance delivery of its CAR-T cell therapy products.
“The certainty of timely and dependable viral vector production supplied by our own facility provides an additional level of control essential for reliably delivering CAR T-cell therapy on a large commercial scale as well as providing supply for clinical trials to develop future treatments,” the spokesperson said.
The 100,000 square-foot Oceanside facility has around 100 employees and Kite says that the operations and capabilities at the plant are “fully scalable”.