London-based cell and gene therapy (CGT) focused firm, Ori Biotech has launched its IRO platform that uses automation to maximize clinical and commercial impact for CGT developers.
The paperless platform has been in stealth mode since 2019. The platform is efficient and flexible, offering a scalable and digital solution for precision medicine manufacturing, the firm said.
“Today ’s CGTs are too hard to manufacture, too expensive to make widely available and not commercially viable due to high costs, low throughput, and lack of reproducibility,” a spokesperson for Ori told BioProcess Insider.
“IRO automates the longest, most manually intensive part of the CGT workflow, including activation, transduction, expansion, and harvest. By reducing labor by up to 70%, reducing the cost of goods by up to 50%, and cutting processing times by up to 25%, IRO allows for quick transition from R&D into the clinic, and from the clinic to commercial-scale manufacturing potentially saving years off therapy development timelines, bringing products to patients more quickly.”
According to the spokesperson, in over 500 internal and external characterization runs, the IRO has demonstrated reliability and efficiency across:
10 Unique Processes - (CAR-T, CAR-M, TCR-T, TILs, CD34+, etc.)
500 runs – conducted at UK site, North American site, and partner sites globally
IRO’s maximum cell yield (~170x fold expansion)
30ml to 1 L: Flexible operating volume range allows activation, transduction and expansion in one bioreactor
Reduction in batch failure rates and consistent delivery of target doses
“We will continue to conduct technology evaluations at partner sites throughout the second half of the year, with the first commercial units planned to be installed at customer sites starting in early 2025. We also hope that 2025 will bring us our first opportunity to support a partner’s clinical trial, which will be the most important milestone for Ori to date,” the spokesperson added.
Prior to the launch of its IRO platform, Ori gave its partners access to the tech under the Lightspeed Early Access Program (LEAP) program, which companies like Inceptor were a part of.