Kite Pharma gets FDA to sign off on new California-based vector manufacturing facility – Endpoints News

Kite Phar­ma just got FDA ap­proval to kick off op­er­a­tions at a new man­u­fac­tur­ing cam­pus.
The can­cer-fo­cused, CAR-T cell ther­a­py play­er made the an­nounce­ment Mon­day, say­ing that the fed­er­al reg­u­la­to­ry agency gave the green light to Kite’s 100,000 square-foot, retro­vi­ral vec­tor man­u­fac­tur­ing fa­cil­i­ty in Ocean­side, CA.
Kite’s glob­al head of tech­ni­cal op­er­a­tions Chris Mc­Don­ald tells End­points News that the fa­cil­i­ty has been in the works for about four years, af­ter Kite teamed up with its par­ent com­pa­ny Gilead. Gilead ac­quired Kite Phar­ma for just shy of $12 bil­lion in 2017.

Chris Mc­Don­ald
Kite has em­ployed 100 work­ers fo­cused on vi­ral vec­tors in the fa­cil­i­ty, and since the build­ing is lo­cat­ed on Gilead’s cam­pus, the par­ent phar­ma will be pro­vid­ing lo­gis­ti­cal sup­port, such as cafe­te­ria staff and build­ing se­cu­ri­ty. The build­ing al­so touts two man­u­fac­tur­ing suites: One is ful­ly ded­i­cat­ed on retro­vi­ral vec­tors in cur­rent com­mer­cial prod­ucts, and the oth­er is set aside for fu­ture ex­pan­sion for pipeline prod­ucts and po­ten­tial­ly dif­fer­ent types of vec­tors.
Vi­ral vec­tors, ac­cord­ing to Mc­Don­ald, are a key in­gre­di­ent need­ed for Kite to make the CAR-T cell ther­a­pies that the biotech has got­ten ap­proved to make for pa­tients, such as Yescar­ta and Tecar­tus. The vec­tors are the in­gre­di­ent that en­code the chimeric anti­gen re­cep­tor in­to a pa­tient’s T cells.
Mc­Don­ald added that the Gilead sub­sidiary is look­ing at au­tomat­ing part of the man­u­fac­tur­ing process so that Kite can be­come more ef­fi­cient. Per Mc­Don­ald:
I think right now, if you went in­to any lab in any uni­ver­si­ty, you’re gonna see staff work­ing un­der a biosafe­ty cab­i­net, you know, mak­ing prod­ucts, etc. And it’s a very man­u­al process and staff are bound quite a bit in asep­tic gown­ing. What we’re work­ing on is re­al­ly de­vel­op­ing an au­toma­tion plat­form that will take a lot of the man­u­al steps away and au­to­mate them and al­so close the man­u­fac­tur­ing process, so that we don’t have to op­er­ate asep­ti­cal­ly, which is a huge ben­e­fit for our staff  — dri­ves a lot of ef­fi­cien­cy.
The op­er­a­tions chief not­ed that this was just on the man­u­fac­tur­ing side. On top of that, the phar­ma is in­ves­ti­gat­ing po­ten­tial op­tions to au­to­mate qual­i­ty con­trol test­ing, as every batch Kite makes is for on­ly one pa­tient.
The Ocean­side site is just the newest ad­di­tion to Kite’s group of man­u­fac­tur­ing fa­cil­i­ties — in­clud­ing oth­ers in Cal­i­for­nia, the Nether­lands, and in Mary­land.