Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform.
The FDA has granted the company’s IRO platform an Advanced Manufacturing Technology (AMT) designation, Ori said Wednesday.
The AMT tag is a stamp of approval for new production approaches that incorporate innovative technology or use established technology in a novel way to substantially improve the drug manufacturing process.
For inclusion into the FDA’s AMT club, a company must demonstrate that its technology can cut development timelines or boost supplies of drugs that are critical or in shortage.
According to the FDA, AMT designations can provide greater quality assurance, helping the industry better meet regulatory standards and strengthen the “regulatory predictability” of the products made with advanced technologies. Likewise, developers employing AMT certified platforms can expect to benefit from a clearer, more streamlined path through the regulatory process.
Ori formally launched its IRO platform last year and is now seeing "rapid adoption by therapy developers, CDMOs, and academic researchers worldwide," the company said Wednesday.
Ori's approach leverages a fully closed system that automates, digitizes and standardizes the most labor-intensive steps of cell and gene therapy manufacturing. IRO has been designed to lower costs, increase throughput, reduce batch failures, accelerate development timelines and enable scalability from R&D through GMP manufacturing, according to the company.
While cell and gene therapies hold great promise—and have made strides, particularly in treating blood cancers and rare diseases—the class of therapies continues to be hindered by manufacturing limitations. In turn, Ori is positioning IRO as an advancement beyond the tubing and flask-based solutions some drugmakers still use.
“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,” Jason Foster, Ori's CEO, said in a Sept. 3 press release. “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.”
Ori was founded a decade ago and took flight in 2020 with a $30 million series A funding round, followed 15 months later by a $100 million series B. Later in 2022, Ori launched its LightSpeed Early Access Program (LEAP), through which it collaborated with an unidentified Big Pharma partner, the MD Anderson Cancer Center and several CDMOs to develop its platform.
Meanwhile, the FDA in April awarded South San Francisco’s Cellares with an AMT designation for its Cell Shuttle manufacturing platform. Cellares' module is roughly the size of a truck and combines the technologies and equipment needed to complete an end-to-end cell therapy production run in a single configuration.
Like Ori, Cellares designed its technology to overcome many of the hurdles and bottlenecks that have long plagued personalized medicine production.