Ori Biotech’s IRO Platform Receives FDA AMT Designation

Ori Biotech, a cell and gene therapy (CGT) manufacturing technology company, has received Advanced Manufacturing Technology (AMT) designation from the U.S. FDA for the IRO platform.

Launched in 2024, IRO is one of the first technologies to receive AMT designation, validating the platform as a next-generation solution to help overcome 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, helping to lower costs, increase throughput, reduce batch failures. The platform is designed to accelerate development timelines and enable scalability from R&D through GMP. 

As legacy tubing and flask-based solutions continue to struggle to meet commercial demands, IRO is seeing rapid adoption by therapy developers, CDMOs, and academic researchers worldwide, according to the company.

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, 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.

“Jason C. Foster, CEO of Ori Biotech, 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. 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.”