AMT designation provides developers using IRO with earlier and more frequent FDA engagement, accelerating regulatory filings and patient access
Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, today announced that the IRO® platform has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration (FDA).
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A multiplex of IROs
Launched in 2024, IRO is one of the first technologies to receive AMT designation, validating the platform as a leading, next-generation solution for overcoming the critical challenges in cell and gene therapy manufacturing. IRO is a fully closed system that automates, digitizes, and standardizes the most labor-intensive steps of cell and gene therapy manufacturing, lowering costs, increasing throughput, reducing batch failures, accelerating development timelines, and enabling scalability from R&D through GMP. Unlike legacy tubing and flask-based solutions, which continue to struggle to meet commercial demands, IRO is seeing rapid adoption by therapy developers, CDMOs, and academic researchers worldwide.
The FDA created the AMT program to encourage adoption of technologies that improve manufacturing reliability, product quality, and scalability, especially for life-supporting or medically critical therapies. For developers using IRO, AMT designation provides earlier and more frequent FDA engagement throughout the IND, NDA, and BLA processes, offering faster feedback, reduced regulatory uncertainty, and a clearer path from early development to commercial launch.
"AMT designation from the FDA is strong validation for the IRO platform as the New Standard in CGT manufacturing," said Jason C. Foster, CEO of Ori Biotech. "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. 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."
"This FDA designation reflects years of rigorous work by the Ori team and our partners," said Thomas Heathman, Ph.D., Chief Commercial Officer of Ori Biotech. "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. With AMT designation, our partners gain not only a proven automation platform but also earlier, more efficient regulatory engagement to accelerate development and improve patient access."
The IRO platform is quickly becoming the New Standard in CGT manufacturing by delivering FDA-recognized innovation that enables shorter time to clinic, faster scale-up, lower COGs and improved reliability-all necessary components to achieving success.
To learn more about the IRO platform, visit Oribiotech.com/IRO.
For further details about AMT visit FDA Advanced Manufacturing Technologies Designation Program.
About Ori Biotech
Ori Biotech is a manufacturing technology company on a mission to enable widespread patient access to life-saving cell and gene therapies. IRO, Ori's next-generation manufacturing platform automates better biology, accelerates product development and enables therapy developers to scale their products' clinical and commercial impact by seamlessly transitioning from R&D to GMP on one platform. The Ori platform automates cell therapy manufacturing, increasing throughput, improving quality and decreasing costs by combining proprietary hardware, consumables, software, data and analytics. For news and updates, visit oribiotech.com/news-insights
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