Kite's viral vector ambitions take flight as the Gilead subsidiary wins FDA nod for SoCal production plant

Kite Pharma's viral vector plant in Southern California has been cleared for liftoff, and, with that, the Gilead Sciences company is touting its position as the only cell therapy player able to make in-house viral vectors for both its pipeline prospects and pair of commercial CAR-Ts.

Monday, the FDA signed off on the Gilead subsidiary’s retroviral vector manufacturing facility in Oceanside, California, for commercial production of the much sought-after cell therapy component.

Viral vectors are engineered viruses used to deliver gene therapies and gene-modified cell therapies—such as Kite’s CAR-Ts Yescarta and Tecartus—as well as certain vaccines. Lately, the industry has been sounding the alarm on a tight viral vector bottleneck as manufacturing approaches struggle to keep pace with the ascent of personalized medicines, plus the rollouts of certain COVID-19 vaccines in recent years.

“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,” Christi Shaw, CEO of Kite, said in a press releaseThe company’s own production capabilities build on a base of external supply partners, too.

Yescarta, first greenlighted in the fall of 2017, is approved in large B-cell lymphoma and follicular lymphoma, while its younger sibling Tecartus holds indications in mantle cell lymphoma and acute lymphoblastic leukemia.

Aside from Kite’s Oceanside facility, the company’s manufacturing network includes plants in El Segundo, California, and the Netherlands plus a recently FDA-approved site in Maryland. Its roster of facilities fills out the “largest dedicated in-house cell therapy manufacturing network in the world,” according to the press release, with capabilities that run the gamut from process development and vector manufacturing to clinical trial production and commercial product manufacturing.

“Kite has continued to increase its manufacturing network capacity to meet increasing demand,” the company added in its release.

Concerning the newly approved Oceanside site, Kite noted in the release that it “continues to invest in its cell therapy workforce,” adding that it employs around 100 staffers at the 100,000-square-foot plant.

The SoCal plant is “fully scalable,” which will enable Kite to “accommodate additional vector manufacturing as cell therapy science advances.”

Kite first telegraphed its plans to tackle viral vector production solo in 2019. The company at the time declined to name its investment in the site or how many employees it aimed to recruit. In July of that same year, Kite laid out plans to begin commercial manufacturing of viral vectors in the second half of 2021.

It isn’t immediately clear what delayed those plans. Kite did not respond to Fierce Pharma’s request for comment.

Meanwhile, back in April, the FDA gave a thumbs-up to commercial cell therapy production at Kite’s facility in Frederick, Maryland. At the time, Kite said it aimed to have 400 employees stationed at the Maryland facility by the end of 2022. After further optimizations across its plants in Southern California and Amsterdam, Kite said it expected to increase its CAR-T manufacturing capacity by 50%.