Cellino 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 designation highlights the potential of Cellino’s automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies.

Autologous iPSC manufacturing has been one of the most complex challenges in biomanufacturing. These hurdles have slowed progress, preventing many therapeutic programs from advancing past early-phase clinical trials. 

Cellino’s proprietary optical bioprocessing technology introduces precision, reproducibility, and scalability, ensuring reliable, high-quality iPSC production for clinical trials and commercial stages.

The company intends to leverage the AMT designation to expedite the translation of personalized iPSC-derived therapies into clinical practice. 

Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino, said, “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.”

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. This offers 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.