Cellino secures FDA AMT designation for automated iPSC manufacturing platform

The U.S. Food and Drug Administration has awarded Cellino an Advanced Manufacturing Technology (AMT) designation for its optical biomanufacturing process used to generate induced pluripotent stem cells (iPSCs).

The recognition, issued through the agency’s Center for Biologics Evaluation and Research, positions the Cambridge‑based firm to engage early and more frequently with regulators during future IND, BLA, and NDA reviews.

The AMT program is designed to speed adoption of technologies that improve product quality, reliability and scale. Under the designation, therapies produced with Cellino’s automated platform will receive prioritized regulatory attention and the option for rolling data submissions, potentially shortening time to market.

Cellino’s approach replaces manual passaging and colony picking with a laser‑based system that selects, edits and expands iPSC colonies in closed, automated cartridges. The company says the technology reduces operator variability and supports consistent, large‑batch production — an important step for advancing autologous iPSC therapies that have historically stalled in early‑stage trials due to manufacturing bottlenecks.

With chronic degenerative diseases on the rise and more than 100 million U.S. patients who could benefit from cell‑based interventions, Cellino plans to leverage the AMT pathway to accelerate its personalized regenerative‑medicine pipeline from Phase 1 through commercial scale.