CAMBRIDGE, Mass. — Cellino, a biotech company focused on advanced biomanufacturing, has received the U.S. Food and Drug Administration’s Advanced Manufacturing Technology (AMT) designation for its proprietary method of producing induced pluripotent stem cells (iPSCs). The designation, awarded by the FDA’s Center for Biologics Evaluation and Research (CBER), signals federal recognition of the company’s automated, optical biomanufacturing platform as a potentially transformative technology in regenerative medicine.
The AMT designation is part of an FDA initiative to promote innovative manufacturing methods that can improve product quality, consistency, and scalability. It provides manufacturers with prioritized agency review and increased engagement throughout regulatory processes, including Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) submissions. For Cellino, this means an opportunity to accelerate the development and market entry of therapies based on its iPSC production platform.
“We are honored to receive the AMT designation for our proprietary technology stack,” said Cellino CEO and Co-Founder Dr. Nabiha Saklayen. “This recognition affirms our commitment to revolutionizing the production of patient-specific iPSCs, enabling faster and more consistent clinical and commercial-scale manufacturing.”
Manufacturing iPSCs has traditionally been a manual, time-consuming, and technically complex process, requiring highly skilled operators. Cellino’s technology replaces many of these manual steps with precision laser-based tools and automated systems that streamline processes such as colony picking and cell passaging. The company claims this approach enhances reproducibility and scalability, making it possible to manufacture patient-specific cells at a clinical and commercial scale.
Dr. Marinna Madrid, Cellino’s Chief Product Officer and Co-Founder, emphasized the broader implications of the designation: “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.”
With more than 100 million Americans potentially eligible for iPSC-derived therapies targeting chronic and degenerative diseases, Cellino sees its platform as a critical tool for expanding access to personalized regenerative medicine. The company plans to use the AMT designation to fast-track development and clinical translation of its therapeutic pipeline.
