Cellino has 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 industrialise next-generation regenerative therapies,” said the company in a statement.

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.

Nabiha Saklayen, CEO and Co-Founder of Cellino said, “We are honoured to receive the AMT designation for our proprietary technology stack. This recognition affirms our commitment to revolutionising 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 personalised 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 labour-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.

Marinna Madrid, Chief Product Officer and Co-Founder of Cellino said, “This AMT designation underscores the scientific rigour and transformative potential of our technology. 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 commercialisation, 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 personalised iPSC-derived therapies into clinical practice. With global chronic disease burdens rising and more than 100 million individuals in the US alone who could potentially benefit from iPSC-derived therapies, Cellino’s technology is poised to significantly expand patient access to next-generation living medicines.