Kite’s Maryland CAR T-cell therapy site gets FDA go-ahead

19-Apr-2022 - Last updated on 19-Apr-2022 at 14:09 GMT

Kite's new CAR T-cell therapy manufacturing facility at Frederick, Maryland, USA © Kite

Related tags CAR T cell therapy Kite Yescarta Gilead

Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

The move follows the US regulator’s recent approval of the use of Kite’s CAR T-cell therapy, Yescarta, in initial treatment for adults with second-line large B-cell lymphoma (LBCL).

Yescarta will be manufactured at the new site.

The Maryland operations joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands, with the company adding that it now has “the largest, dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.”

Kite began construction of the 275,000 square foot (25548.36 sq. m) facility in Maryland on 20 acres in 2019. The site has unfinished space to add future capacity, which Kite said would allow it to accommodate potential new scientific and technological advances in the field.

The facility is purpose-built for cell therapy, incorporating learnings from across the Kite manufacturing network as well as incorporating automation for some previously manual processes, allowing more therapies to be produced to meet growing patient demand, added the developer.

Training center

The company anticipates having over 400 employees working at the Maryland facility by the end of 2022. The site is also set up to train and develop the region’s cell therapy talent through partnerships with local academic institutions as well as community and government organizations.

A spokesperson for Kite told BioPharma-Reporter earlier this month that the company has invested significantly in added manufacturing capacity at its existing locations and, taking account of the new Maryland manufacturing site, it estimated that its manufacturing capacity will be 50% greater than it was just a year ago.

"CAR T-cell therapy is individually made for each patient from their own T-cells and is a complex process. Manufacturing quality, reliability, and speed are critically important in CAR T-cell therapy, and patients and physicians count on Kite’s 97% reliability to return cells on time and to specification.

"Today, our average US production time from apheresis to product release is only 16 days, and in Europe it is 19 days - and that includes the transportation logistics to get the cells to us,” added the spokesperson.