News
September 10, 2025
Ori Biotech’s IRO Platform Earns FDA Advanced Manufacturing Technology Designation
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 ...
Ori Biotech, a cell and gene therapy (CGT) manufacturing technology company, announced today that its innovative IRO® platform has been granted Advanced Manufacturing Technology (AMT) designation by the U.S. Food and Drug Administration (FDA). This significant achievement underscores the platform's potential to revolutionize the production of life-saving cell and gene therapies.
The FDA's AMT designation is reserved for novel technologies that have the potential to improve the manufacturing process for drugs and biological products. This recognition highlights the IRO® platform's innovative approach and its promise to enhance efficiency, safety, and accessibility in the CGT manufacturing landscape.
Cell and gene therapies hold immense promise for treating a wide range of diseases, including cancers, genetic disorders, and autoimmune conditions. However, the complex and often manual nature of current manufacturing processes presents a significant bottleneck in bringing these therapies to patients. Traditional methods are often costly, time-consuming, and prone to variability, hindering widespread adoption.
The IRO® platform addresses these challenges by offering an automated and closed system for CGT manufacturing. This integrated approach minimizes the risk of contamination, reduces manual handling, and enhances process control, ultimately leading to more consistent and reliable product quality. The platform's modular design allows for flexibility and scalability, accommodating a variety of cell types and therapeutic applications.
By receiving the AMT designation, Ori Biotech gains several advantages, including increased interaction with the FDA during the development and regulatory review process. This collaboration can facilitate a smoother and faster path to market for CGTs manufactured using the IRO® platform. The designation also serves as a validation of the technology's potential and can attract further investment and partnerships.
"This designation from the FDA is a testament to the transformative potential of the IRO® platform," said a representative from Ori Biotech. "We believe that our technology can play a crucial role in accelerating the development and delivery of cell and gene therapies to patients in need." The company is committed to working closely with the FDA and the broader CGT community to realize the full potential of advanced manufacturing technologies and improve patient outcomes.
The FDA's AMT designation is reserved for novel technologies that have the potential to improve the manufacturing process for drugs and biological products. This recognition highlights the IRO® platform's innovative approach and its promise to enhance efficiency, safety, and accessibility in the CGT manufacturing landscape.
Cell and gene therapies hold immense promise for treating a wide range of diseases, including cancers, genetic disorders, and autoimmune conditions. However, the complex and often manual nature of current manufacturing processes presents a significant bottleneck in bringing these therapies to patients. Traditional methods are often costly, time-consuming, and prone to variability, hindering widespread adoption.
The IRO® platform addresses these challenges by offering an automated and closed system for CGT manufacturing. This integrated approach minimizes the risk of contamination, reduces manual handling, and enhances process control, ultimately leading to more consistent and reliable product quality. The platform's modular design allows for flexibility and scalability, accommodating a variety of cell types and therapeutic applications.
By receiving the AMT designation, Ori Biotech gains several advantages, including increased interaction with the FDA during the development and regulatory review process. This collaboration can facilitate a smoother and faster path to market for CGTs manufactured using the IRO® platform. The designation also serves as a validation of the technology's potential and can attract further investment and partnerships.
"This designation from the FDA is a testament to the transformative potential of the IRO® platform," said a representative from Ori Biotech. "We believe that our technology can play a crucial role in accelerating the development and delivery of cell and gene therapies to patients in need." The company is committed to working closely with the FDA and the broader CGT community to realize the full potential of advanced manufacturing technologies and improve patient outcomes.
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