Cellino Secures FDA Designation for Cutting-Edge iPSC Manufacturing Technology
In a significant advancement for regenerative medicine, Cellino has announced that its innovative optical biomanufacturing technology for producing induced pluripotent stem cells (iPSCs) has received the Advanced Manufacturing Technology (AMT) designation from the FDA’s Center for Biologics Evaluation and Research (CBER). This milestone underscores the transformative potential of Cellino’s automated platform, which aims to industrialize high-quality iPSC manufacturing for next-generation therapies.
Historically, the production of autologous iPSCs has posed one of the toughest challenges in biomanufacturing, significantly slowing progress and hindering many therapeutic programs from moving beyond early-phase clinical trials. Cellino’s proprietary technology addresses these complexities by ensuring precision, reproducibility, and scalability, which are vital for reliable production at both clinical and commercial levels.
Dr. Nabiha Saklayen, CEO and Co-Founder of Cellino, expressed her enthusiasm about the recognition, stating, “This acknowledgment reaffirms 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’s AMT designation not only endorses Cellino’s technology but also enhances the agency’s support for the rapid adoption of advanced manufacturing practices, improving the reliability and quality of therapeutic products. By streamlining the regulatory process, this designation provides Cellino a faster pathway for therapies using their optical biomanufacturing technology, ensuring priority during critical steps such as Investigational New Drug (IND) and Biologics License Application (BLA) processes.
Cellino’s advancements set the stage for significant strides in personalized medicine, with the potential to vastly improve patient care and treatment outcomes.
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