Ori Biotech, a UK-based manufacturing technology company, is a leader in cell and gene therapy (CGT) manufacturing innovation. The company’s mission is to enable widespread patient access to these life-saving therapies.
Ori’s research and development and commercialisation of the IRO platform have been supported by venture funding alongside a previously awarded Innovate UK Smart grant. Both have accelerated the company’s innovation and growth.
Next-generation platform streamlines therapy manufacturing
Launched in 2024, IRO is a next-generation manufacturing platform designed to overcome current CGT manufacturing challenges. It helps therapy developers automate better biology, accelerate product development and enable scalability needed to achieve clinical and commercial success.
The fully automated, closed, digital system streamlines many complex manual steps involved in manufacturing. Compact, modular hardware and consumables are combined with cloud-based software, to help accelerate process development and more efficient manufacturing.
IRO is the first British technology to receive US Food and Drug Administration (FDA) Advanced Manufacturing Technology designation. This recognizes its potential to improve reliability, scalability, and product quality in CGT manufacturing. The designation also allows therapy developers to engage with the FDA earlier and more frequently, helping to accelerate therapies to the clinic and shorten overall development timelines.
Real-time monitoring improves product consistency
With support from an Innovate UK Smart grant, Ori advanced a critical innovation area in real-time, non-invasive process monitoring within IRO.
Many legacy CGT manufacturing platforms rely on periodic manual sampling to track key indicators of product quality, such as pH, oxygen and nutrient levels. This approach can be time-consuming, costly and may introduce variability.
Ori Biotech’s IRO platform, designed to support flexible and scalable cell and gene therapy manufacturing. Credit: Ori Biotech
Smart grant drives sensor integration
Through the Innovate UK-funded project, Ori evaluated multiple sensing technologies and created custom prototypes that could operate reliably within IRO. The company adopted PreSens optical sensors to measure pH and dissolved oxygen, demonstrating the required performance in representative manufacturing scenarios.
This capability is now built into the commercial IRO platform, providing real-time data to support more consistent production of advanced therapies.
Stuart Milne, Chief Technology Officer, Ori Biotech said:
This project proved that real-time, non-invasive monitoring is feasible in a digitally enabled, closed cell therapy platform such as IRO. Innovate UK’s support helped de-risk a critical innovation area and informed a valuable feature of the platform.
Non-invasive monitoring enhances manufacturing efficiency
The Innovate UK project contributed to IRO’s real-time monitoring as part of Ori’s broader platform development and commercialisation. Between 2020 and 2024, Ori expanded its UK team, creating roles across engineering, operations, software, biology and project management. The company also established collaborations with UK suppliers, design consultancies and manufacturing partners, strengthening the country’s advanced therapy capabilities.
Ori’s work addresses a central barrier to access. Fewer than 5% of eligible patients globally receive CAR-T therapies, partly due to manufacturing complexity. By introducing closed, digital, best-of-breed automation, IRO supports more reliable, scalable and efficient production, helping advanced therapies reach more patients sooner, in the UK and beyond.