Ori Biotech, a cell and gene therapy (CGT) manufacturing technology company based in London and New Jersey, said its IRO platform has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration (FDA).
Launched in 2024, the IRO system automates, digitizes and standardizes labor-intensive steps of CGT manufacturing in a fully closed system. The company said the platform reduces costs, increases throughput, lowers batch failure rates and enables scalability from research through GMP manufacturing. According to Ori, the FDA designation validates IRO as one of the first next-generation technologies recognized under the program.
The FDA created the AMT initiative to encourage manufacturers to adopt advanced tools that improve reliability, product quality and scalability for medically critical therapies. With the designation, developers using IRO will gain earlier and more frequent engagement with the FDA throughout regulatory processes, the company said.
“IRO gives therapy developers both the flexibility needed early in development and the scalability required to achieve commercial success without losing control of their process and their future,” said Jason Foster, CEO of Ori Biotech, in a statement. “It is very clear that legacy systems can’t meet today’s manufacturing demands, while advanced manufacturing technologies like the IRO platform are what the cell and gene therapy industry requires to ensure that the next generation of therapies achieve both clinical and commercial success.”
Thomas Heathman, chief commercial officer at Ori Biotech, added that IRO is “having an impact in real-world settings, automating better biology to reduce variability, improve performance, and support scalable CGT manufacturing from early development through commercial launch.”
In other recent news, Ori Biotech announced a collaboration with MaxCyte to integrate its IRO platform with MaxCyte’s ExPERT Flow Electroporation system for autologous cell therapies. The collaboration will evaluate the IRO system’s role in improving efficiency in the production of CRISPR-edited CAR T cells.