FDA signs off on Gilead­'s mas­sive new CAR-T man­u­fac­tur­ing site in Mary­land

Ear­li­er this month, Gilead’s Kite land­ed an ap­proval for Yescar­ta in large B-cell lym­phoma, mak­ing it the first CAR-T avail­able in the sec­ond-line lym­phoma set­ting. On Tues­day, the com­pa­ny an­nounced the ap­proval of its new man­u­fac­tur­ing site in Mary­land by the FDA.

The site will join ex­ist­ing sites in Cal­i­for­nia and Am­s­ter­dam to in­crease its cell ther­a­py man­u­fac­tur­ing ca­pac­i­ty by 50%. It fea­tures process de­vel­op­ment, vec­tor man­u­fac­tur­ing, and clin­i­cal tri­al and com­mer­cial prod­uct man­u­fac­tur­ing.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER