Two manufacturing tech developers have independently detailed their own approaches that could improve the cost and timelines to make cell and gene therapies and CAR-T products.
On Wednesday, Ori Biotech unveiled its CGT manufacturing platform that could cut costs in half and reduce production time by 25%. Meanwhile, Cytiva and Kite — Gilead’s cell therapy arm — revealed their own platform to increase manufacturing of CAR-T therapies by 50%.
Jason Foster“We’re in a constrained supply environment. We just can’t physically treat enough patients with cell and gene therapies,” Ori CEO Jason Foster told Endpoints News in an interview. Around 95% of patients do not have access to CGT due to the high cost and length of time to make the drugs, Ori said.
Ori’s platform, dubbed IRO, is a white box that looks like a locker. Each box could make a single patient dose in around two to three days, down from the current timeline of eight to 10 days, Foster said. Typically, cell therapies cost around $500,000 per patient, but IRO can potentially cut these costs by reducing manual labor, he added.
To reduce variability and inefficient use of reagents, IRO automates certain processes, Foster said. The platform also uses cloud technology that produces data every seven seconds, giving a complete picture of the manufacturing process, he said.
The company can also transfer a client’s cell therapy manufacturing process, which typically takes around six to nine months, onto Ori’s platform within about five weeks, further cutting down manufacturing timelines, Foster said.
A room no larger than a two-car garage can fit roughly 30 IRO boxes that can run at the same time to produce a thousand doses of CGT a year. This reduces needed manufacturing space compared to typical methods, which need a space about as large as a four-bedroom house to produce the same number of doses annually.
Ori launched in January 2020 with seed funding of $9.4 million and then raised a further $30 million in a Series A nearly a year later. In January 2022, a Series B round pulled in another $100 million for the company.
Cytiva and Kite collab
Meanwhile, Cytiva and Kite launched Sefia, an automated manufacturing platform that uses two different machines to make CAR-T therapies, according to a Wednesday release.
The first machine, the Sefia Select system, automates cell isolation, harvest and formulation, while the Sefia expansion system controls cell activation, transduction and cell expansion.
Sefia can produce CAR-T therapies in around eight to nine days, according to a product brochure. Similar to Ori Biotech’s platform, Sefia could help to reduce facility sizes and the number of employees needed to run the manufacturing processes, according to Cytiva.