Orca Bio looks to increase its cell therapy manufacturing capacity with a new facility in Sacramento – Endpoints News

While Or­ca Bio has net­ted some ma­jor mile­stones, such as a $192 mil­lion Se­ries D and a re­gen­er­a­tive med­i­cine ad­vanced ther­a­py (RMAT) des­ig­na­tion from the FDA, the com­pa­ny is look­ing to step up things on the man­u­fac­tur­ing side of the busi­ness.

Or­ca Bio will ex­pand its man­u­fac­tur­ing ca­pa­bil­i­ties by con­struct­ing a new 100,000-square-foot com­mer­cial fa­cil­i­ty in Sacra­men­to, CA.

In an in­ter­view with End­points News, Or­ca Bio COO Jeroen Bekaert said the biotech is now evolv­ing in­to a late-stage cell ther­a­py com­pa­ny and is start­ing its Phase III with the Or­ca-T prod­uct, which has in­creased their need for man­u­fac­tur­ing space.

“The new fa­cil­i­ty specif­i­cal­ly will fo­cus on man­u­fac­tur­ing for our late-stage clin­i­cal pipeline, as well as our fu­ture com­mer­cial ca­pac­i­ty, while the ex­ist­ing fa­cil­i­ty we have in Sacra­men­to is main­ly go­ing to fo­cus on the ear­ly-stage pipeline,” Bekaert told End­points.

Bekaert said that while the ex­pan­sion is cen­tered around late-stage stud­ies, it will al­so be suit­ed for any po­ten­tial com­mer­cial launch if the prod­uct gets past the clin­i­cal stage. He al­so said that as treat­ments with its prod­uct in­crease, Or­ca Bio wants to have ded­i­cat­ed fa­cil­i­ties for ear­ly- and late-stage prod­ucts, and is there­fore keep­ing its oth­er 10,000-square-foot space in Sacra­men­to.

The cost and the head­count of the fa­cil­i­ty have not been dis­closed, but Bekaert said that projects such as these can be very cash-in­ten­sive. Con­struc­tion at the site start­ed last Au­gust, but the biotech hopes that it can be com­plet­ed lat­er this year and be ful­ly on­line by the first half of next year.

Bekaert said the site will con­tain sev­er­al pro­duc­tion suites for its cell ther­a­pies, which can be scaled per de­mand. The site will al­so con­tain qual­i­ty con­trol labs and ad­min­is­tra­tive spaces.

Bekaert al­so em­pha­sized that Or­ca Bio has been work­ing in­tent­ly on op­ti­miz­ing its cell se­lec­tion process­es and de­vel­op­ing au­toma­tion steps wher­ev­er pos­si­ble, and that will al­so play a heavy role in the fa­cil­i­ty. He al­so said that the com­pa­ny be­ing in Sacra­men­to gives Or­ca Bio ac­cess to a wide tal­ent pool from lo­cal uni­ver­si­ties. And with the fa­cil­i­ty be­ing near the Sacra­men­to air­port, it hopes to cut down on ship­ping times and costs.

“We hope to con­tin­ue to demon­strate that we can de­liv­er prod­ucts to pa­tients with­in 72 hours re­gard­less of where the donor pa­tient is based in the US,” he said.

Or­ca Bio is not the on­ly place that is look­ing to boost its cell ther­a­py man­u­fac­tur­ing ca­pa­bil­i­ties. Ear­li­er this sum­mer, the Cen­ter for Break­through Med­i­cines stat­ed that it will in­crease its ca­pac­i­ty to man­u­fac­ture more than 10,000 pa­tient ther­a­pies at its Penn­syl­va­nia head­quar­ters.

In Au­gust, two CD­MOs on op­po­site sides of the At­lantic merged to in­crease their reach in cell ther­a­py man­u­fac­tur­ing as well.