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Provides developers using IRO with earlier and more frequent FDA engagement to help accelerate regulatory filings.
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 o...
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