Ori Biotech, a cell and gene therapy manufacturing technology company, has received Advanced Manufacturing Technology (AMT) designation from the U.S. FDA for its IRO platform, making it one of the first technologies to achieve this recognition since the platform's launch in 2024.
Revolutionary Manufacturing Platform
The IRO platform operates as a fully closed system that automates, digitizes, and standardizes the most labor-intensive steps of cell and gene therapy manufacturing. This comprehensive approach helps lower costs, increase throughput, reduce batch failures, and accelerate development timelines while enabling scalability from research and development through Good Manufacturing Practice (GMP) standards.
The platform is designed to address the limitations of legacy tubing and flask-based solutions, which continue to struggle to meet commercial demands in the rapidly expanding cell and gene therapy sector. According to Ori Biotech, IRO is experiencing rapid adoption by therapy developers, contract development and manufacturing organizations (CDMOs), and academic researchers worldwide.
FDA Recognition and Regulatory Benefits
The FDA created the AMT program to encourage adoption of technologies that improve manufacturing reliability, product quality, and scalability for life-supporting critical therapies. For developers using IRO, the AMT designation provides significant regulatory advantages, including earlier and more frequent FDA engagement throughout the Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) processes.
This enhanced regulatory pathway offers faster feedback, reduced regulatory uncertainty, and a clearer path from early development to commercial launch for therapy developers utilizing the platform.
Industry Impact and Leadership Perspective
"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, emphasized the platform's real-world impact: "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."
Commercial Advantages
The IRO platform is positioning itself as the new standard in cell and gene therapy 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 factors for achieving success in the competitive cell and gene therapy field.
