After half a decade spent developing an automated manufacturing platform, Ori Biotech believes it's ready to make a mark on the cell and gene therapy field.
Ori on Wednesday revealed its IRO platform, a piece of manufacturing tech designed to be space- and cost-efficient. The company says its tech is flexible enough to transition between projects at various stages of development.
The IRO platform can slash labor and production costs while curbing processing times, the company said during a launch reveal at the International Society for Cell & Gene Therapy’s (ISCT’s) 2024 annual conference in Vancouver.
While cell and gene therapies hold great promise—and have made strides when it comes to treating blood cancers—the class of advanced therapies continues to be held back by manufacturing limitations, Ori said in a press release Wednesday.
Ori estimates that more than 95% of patients who could benefit from a cell or gene therapy are left without access thanks to common production hurdles related in large part to scalability and cost.
To tackle those problems, Ori has designed its IRO platform to automate, digitize and standardize the “most time-consuming and labor-intensive parts of the cell and gene therapy manufacturing workflow,” the company explained in a release.
Holding out for an IRO
“The science has advanced incredibly quickly, but the infrastructure behind that science hasn’t developed at the same pace,” Jason Foster, Ori’s CEO, said in an interview. “So, we’ve been running like heck for the last five years to develop this process as fast as we can.”
According to Foster, Ori’s platform rests on three pillars: a novel bioreactor system, automation and the platform’s cloud-native digital component, which the CEO says allows Ori to capture and subsequently process data every seven seconds.
The physical instrument in Ori’s manufacturing platform is about the size of a microwave oven. The devices can be stacked vertically or horizontally to increase capacity.
“Increasing throughput, reducing the footprint, reducing variability and reducing costs are the critical success factors for us,” the Ori CEO explained.
From LEAP to launch
While Ori’s market debut has been years in the making, the company has already placed its technology in the hands of experts in the real world through the LightSpeed Early Access Program (LEAP) it launched in early 2022.
Since LEAP’s launch, Ori has worked with five different partners, including a “big pharma partner,” plus several CDMOs and MD Anderson Cancer Center, Foster explained.
By acquiring feedback on its platform in the real world, Ori has been able to use LEAP to inform the parameters of its commercial debut, Foster explained.
The company has been building out its commercial workforce too, with Foster pointing to the recent hiring of Ori's new chief operating officer John Machulski and chief financial officer Gillian Bonthron, plus infrastructure buildout to store inventory, take orders and build and deliver products.
Under the current launch plan, Ori plans to deploy its first IRO units to the market by the first quarter of 2025, Foster said.
Until then, Ori will spend the second half of 2024 performing “feasibility work” with 5 to 10 partner organizations to help them acclimate to the technology. Around four partners have already signed up for their chance to test the tech later this year, Foster said.
Aside from big pharmas, small biotechs and CDMOs, Ori will also target the academic research community with its launch, Foster pointed out.
The automation crowd
Ori Biotech isn’t alone in its quest to automate cell and gene therapy production, with companies such as Multiply Labs and Cellares also entering the fold in recent years.
In April, Cellares scored a major break when it inked a $380 million deal to provide CAR-T manufacturing space for Bristol Myers Squibb utilizing its compact, automated cell therapy manufacturing units. News of the BMS deal came just four days after Cellares launched its automated quality control unit Cell Q.
As for Multiply Labs, the company's robotics platform has yielded a partnership with Thermo Fisher.
Elsewhere in the field, Japan's Astellas and Yaskawa Electric Corporation last week agreed to explore potential advancements in automated cell therapy production.
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