Accelerate Your CGT Pipeline With The FDA-Designated Advanced Manufacturing Technology Program

Cell and gene therapies (CGTs) hold extraordinary promise for treating cancer and rare diseases, yet their manufacturing remains a major barrier to patient access. Current processes rely on labor-intensive, manual methods with high variability and failure rates, leading to costly delays, regulatory setbacks, and, most critically, missed treatment opportunities for patients in need. To address these challenges, the FDA launched its Advanced Manufacturing Technologies (AMT) Designation program in 2024 to accelerate the adoption of next-generation technologies that improve scalability, reliability, and cost-effectiveness in CGT production.

Oribiotech’s IRO platform is among the first recipients of the AMT designation. IRO is a flexible, automated, cloud-connected system that reduces batch failures, doubles output, and enables rapid scale-up from preclinical to commercial manufacturing. By streamlining complex processes and ensuring regulatory alignment, AMT-designated platforms like IRO are redefining how CGTs move from lab to market — and ultimately, to the patients who need them most. Download the full article to learn more about this groundbreaking technology.