Ori Biotech, a frontrunner in cell and gene therapy manufacturing technology, has announced that its IRO® platform has been granted Advanced Manufacturing Technology (AMT) designation by the U.S. Food and Drug Administration (FDA). This designation is a significant milestone, marking IRO as one of the first technologies to receive this recognition since its launch in 2024, and emphasizes its role as a cutting-edge solution for the challenges faced in cell and gene therapy manufacturing.

The IRO platform operates as a fully closed system, automating, digitizing, and standardizing the most labor-intensive processes involved in manufacturing cell and gene therapies. This advancement results in reduced costs, increased throughput, decreased batch failures, and accelerated development timelines, while also providing scalability from research and development (R&D) to Good Manufacturing Practice (GMP). In contrast to outdated tubing and flask-based solutions, which struggle with commercial demands, IRO is rapidly being adopted by therapy developers, contract development and manufacturing organizations (CDMOs), and academic researchers globally.

The AMT program established by the FDA aims to promote the use of technologies that enhance manufacturing reliability, product quality, and scalability, particularly for life-saving or medically essential therapies. For developers utilizing IRO, the AMT designation facilitates earlier and more frequent interactions with the FDA throughout the Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) processes. This leads to quicker feedback, diminished regulatory uncertainty, and a more streamlined transition from early-stage development to commercial launch.

“AMT designation from the FDA is strong validation for the IRO platform as the New Standard in CGT manufacturing,” stated 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.”

Thomas Heathman, Ph.D., Chief Commercial Officer of Ori Biotech, added, “This FDA designation reflects years of rigorous work by the Ori team and our partners. 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 establishing itself as the New Standard in CGT manufacturing by delivering FDA-recognized innovation that enables shorter time to clinic, faster scale-up, lower costs of goods sold (COGs), and enhanced reliability—all crucial for achieving success in this field.