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.