Cellino’s iPSC Biomanufacturing Technology Receives FDA Advanced Manufacturing Technology Designation
Tuesday, May 20, 2025
Cellino has received recognition from the US Food and Drug Administration (FDA) for its optical biomanufacturing technology used in the production of induced pluripotent stem cells (iPSCs). The company’s platform has been granted the Advanced Manufacturing Technology (AMT) designation by the FDA’s Center for Biologics Evaluation and Research (CBER), highlighting its potential to support the industrial-scale development of next-generation regenerative therapies.
The AMT designation is part of an FDA initiative aimed at encouraging the use of modern manufacturing technologies that enhance reliability, improve product quality, and support greater production capacity. Technologies awarded this status benefit from regulatory support such as earlier and more frequent engagement with the FDA, which can help accelerate the development and approval of therapies during various regulatory stages, including IND, NDA, and BLA submissions.
Cellino’s platform is designed to automate the production of high-quality iPSCs, which are essential in the development of personalised regenerative treatments. Traditional autologous iPSC manufacturing is a complex and manual process that requires highly skilled personnel and involves labour-intensive tasks such as cell passaging and colony selection. These challenges have slowed the progress of many cell-based therapies, limiting their transition beyond early clinical phases.
By replacing manual methods with an automated, optical approach, Cellino’s technology aims to deliver greater precision, consistency, and scalability. This could improve access to iPSC-based therapies for clinical trials and broader commercial applications.
The AMT designation also reflects the scientific foundation of Cellino’s approach and its potential to streamline the production of regenerative medicines. The company plans to use this recognition to advance the clinical adoption of patient-specific, iPSC-derived therapies more quickly.
As chronic degenerative diseases continue to rise globally, Cellino’s scalable manufacturing solution may help meet increasing demand. In the United States alone, over 100 million people could benefit from iPSC-based treatments. With its new designation, Cellino is positioned to contribute to wider access to personalised regenerative healthcare.
Source: businesswire.com
