Despite technological advances in cell and gene therapy (CGT) manufacturing, these potentially transformative therapies remain complex, costly, and difficult to manufacture at-scale. To address these challenges, London and Philadelphia-based Ori Biotech has developed a proprietary and flexible manufacturing platform that it contends could help accelerate therapy development and expand patient access to life-saving CGT products.
When it comes to CAR T-cell therapy, Ori CEO Jason Foster told Pharma Manufacturing that “the major challenge that we’re facing as an industry is how do we get these products to patients — we literally have a cure for cancer that patients can’t get access to.”
Two out of 10 patients in the U.S. are able get access to treatment but “the rest of the world basically has almost zero access to these products,” according to Foster.
By automating and digitizing critical processes, Ori’s IRO platform is designed to streamline manufacturing workflows to overcome bottlenecks that currently limit patient access. At the same time, IRO supports both research and development and GMP manufacturing on the same system, offering a seamless transition between the two.
“When you try and take a lab-scale process and turn it into a GMP commercial-scale process, it doesn’t work and you get a very expensive, highly variable, low-throughput process that ultimately leads us to the place we’ve reached unfortunately with the first-generation CAR T products,” Foster said. However, he contends that “flexibility and scalability in the same platform are the core principles” of Ori’s platform.
IRO’s R&D flexibility allows for the optimization of processes, while maintaining precision and control that is critical for GMP manufacturing. The platform reduces demands on labor by up to 70%, lowers the cost of goods by up to 50%, cuts processing times by up to 25%, and shortens tech transfer timelines from months to just weeks, according to Ori.
“The IRO platform has been designed specifically to be able to do R&D translation, process development, clinical-scale manufacturing, GMP, and also commercial-scale manufacturing,” Foster said. “The same instrument, the same consumables, the same process, the same reagents can be taken all the way through from development through the clinical trial process to commercial scale.”
The IRO instrument — which is about the size of a large microwave oven turned on its end — automates the core parts of the CGT manufacturing process, increasing throughput by between 10 times and 50 times that achieved with existing manual manufacturing processes, according to Foster. While the platform currently automates about 70% of today’s workflow, he said “there’s still 30% upstream and downstream that will have to be automated.”
Ori announced in December 2024 a collaboration with Fresenius Kabi to integrate the IRO platform with Fresenius’ Cue and Lovo cell processing systems. The partnership is aimed at reducing manual handling and streamlining production steps. The companies describe the approach as offering a closed system for upstream and downstream processing.
Foster contends that IRO cuts the cost of goods by up to 50% by reducing the need for a highly skilled workforce and by using expensive reagents more efficiently. With the platform, he claims the out of specification (spec) rate — the percentage falling outside the specification limits — drops to less than 5%, compared to an industry out of spec rate of between 20% and 40%.
In January 2025, Ori announced the first customer deliveries of IRO. The platform has been deployed to multiple contract development and manufacturing organizations (CDMOs) and a Big Pharma company that has a commercial CAR-T therapy product in the market.
“We’re partnering with the leading CDMOs and academic research centers, as well as the leading technology providers,” Foster said. “That best-of-breed approach is really what’s going to drive the best result for the industry.”
