The Gilead company says the approval makes it the only cell therapy company with in-house viral vector manufacturing capabilities for both clinical trials and commercial products. Furthermore, it strengthens the company’s global CAR T-cell therapy manufacturing network as it sees growing demand for its blood cancer treatments.
‘This milestone is several years in the making’
Over 10,000 patients have been treated with Kite’s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 cancer hospitals in the US.
Viral vectors are key components needed to manufacture Kite’s cell therapies to treat certain blood cancers. These CAR T-cell therapies are one-time treatments individually made starting from a patient’s own T-cells.
“The FDA approval of our [Oceanside] 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 Kite’s CEO Christi Shaw. “This milestone is several years in the making and reflects our continued commitment to, and investment in, bringing the curative intent of cell therapy to patients.”
The 100,000 square foot space at the Oceanside facility employs around 100 people. Furthermore, the capabilities and operations are fully scalable and will allow the company to accommodate additional vector manufacturing as cell therapy science advances.