PHILADELPHIA, PA & LONDON — Ori Biotech announced that its IRO® platform has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration, marking it as one of the first technologies to earn the recognition since the program’s creation.
Launched in 2024, IRO is a fully closed system designed to automate, digitize, and standardize the most labor-intensive steps in cell and gene therapy (CGT) manufacturing. The platform addresses key challenges in the field by lowering production costs, increasing throughput, reducing batch failures, accelerating development timelines, and enabling scalability from research through commercial manufacturing.
Unlike traditional tubing- and flask-based methods, which often struggle to meet commercial demands, IRO is seeing rapid adoption among therapy developers, contract development and manufacturing organizations (CDMOs), and academic researchers globally.
The FDA’s AMT program was established to promote the use of innovative technologies that improve manufacturing reliability, product quality, and scalability, particularly for therapies considered life-supporting or medically critical. For developers using IRO, the designation offers earlier and more frequent engagement with the FDA throughout investigational and regulatory phases, helping streamline the 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.”
Thomas Heathman, Ph.D., Ori Biotech’s chief commercial officer, said the designation underscores the platform’s growing real-world impact. “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,” Heathman said.
Ori Biotech said the FDA’s recognition not only validates the IRO platform’s capabilities but also provides its partners with a more efficient regulatory pathway to bring advanced cell and gene therapies to patients faster.
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