Cellino’s iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation

AMT Designation Positions Cellino to Accelerate the Development of Scalable, Personalized Regenerative Medicines

Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) has received the FDA’s Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER). This prestigious designation highlights the transformative potential of Cellino's automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies.

The FDA encourages the adoption of advanced manufacturing technologies (AMTs) that improve manufacturing reliability, product quality, and production scale. The AMT designation accelerates timelines for therapies manufactured using Cellino’s optical biomanufacturing technology, offering higher priority within the FDA, along with earlier and more frequent interactions during Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) processes for a faster path to market.

“We are honored to receive the AMT designation for our proprietary technology stack,” said Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino. “This recognition affirms our commitment to revolutionizing the production of patient-specific iPSCs, enabling faster and more consistent clinical and commercial-scale manufacturing. It’s a pivotal moment in our mission to deliver personalized regenerative therapies that can scale globally, transforming healthcare for millions.”

Autologous iPSC manufacturing has long been one of the most complex challenges in biomanufacturing, involving labor-intensive processes like manual passaging and colony picking that only a limited number of experts worldwide can perform. These hurdles have slowed progress, preventing many therapeutic programs from advancing past early-phase clinical trials. Cellino’s proprietary optical bioprocessing technology overcomes these challenges by introducing precision, reproducibility, and scalability, ensuring reliable, high-quality iPSC production for both clinical trials and commercial stages.

“This AMT designation underscores the scientific rigor and transformative potential of our technology,” said Marinna Madrid, Ph.D., Chief Product Officer and Co-Founder of Cellino. “Automated, optical manufacturing is key to ensuring patient access to regenerative medicines. This milestone brings us closer to scaling therapies from Phase 1 through large-scale commercialization, aiming to address some of the world’s most debilitating chronic degenerative diseases.”

Cellino intends to leverage the AMT designation to expedite the translation of personalized iPSC-derived therapies into clinical practice. With global chronic disease burdens rising and more than 100 million individuals in the U.S. alone who could potentially benefit from iPSC-derived therapies, Cellino’s technology is poised to significantly expand patient access to next-generation living medicines.

For more information on the FDA’s Advanced Manufacturing Technologies Designation Program, visit the FDA AMT Guidance.

About Cellino

Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at www.cellinobio.com and follow us on LinkedIn and X.

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