Yokohama, Japan July 22nd – REPROCELL is pleased to announce the successful submittal of its StemRNA™ Clinical iPSC Seed Clones with the US Food and Drug Administration (FDA) via a Type 2 Drug Master File (DMF).
The DMF submission provides comprehensive documentation, including donor eligibility assessments aligned with FDA standards, iPSC derivation methods, extensive quality control testing, and full disclosure on all raw materials and reagents used in our production process. Manufactured under rigorous standards that satisfy the US FDA, European EMA, and Japanese PMDA, these clinical-grade iPSCs reflect our commitment to excellence and regulatory alignment across the globe.
This milestone follows the FDA Investigational New Drug (IND) clearance for Gameto’s Fertilo platform – powered by our StemRNA™ iPSCs – announced earlier this year. Now, this DMF submittal streamlines regulatory review and enables biotech and pharmaceutical companies to seamlessly reference our clinical iPSC lines within their own regulatory applications for their cell therapy development and applications to the US FDA.
Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., commented: “We are confident that this DMF submittal will streamline regulatory pathways for our partners, accelerating the development of regenerative medicine programs that use our clinical iPS cells.”
This DMF underscores REPROCELL’s commitment to enabling global cell therapy development through high-quality manufacturing, transparency, and regulatory readiness.
What is a DMF?
A DMF is a voluntary, confidential submission to the FDA that details information – such as raw materials, manufacturing processes, and quality controls – used in pharmaceutical or cell therapy products. By referencing our DMF, companies developing regenerative medicine products with REPROCELL’s StemRNA™ Clinical iPSC Seed Clones can streamline FDA regulatory submissions.
About StemRNA™ Clinical iPSC Seed Clones
StemRNA™ iPSCs are powered by our safe and efficient RNA-based reprogramming technology. Produced for clinical applications and compliant with FDA, EMA, and PMDA standards, these seed clones are trusted by leading biopharma companies worldwide as a reliable, high-quality platform for advancing next-generation regenerative therapies.
With the StemRNA™ seed clone DMF now in place, REPROCELL is now positioned to fast-track your cell therapy program – from concept to clinic. Our regulatory-ready, fully vetted iPSC lines remove key development bottlenecks, enabling biotech and pharma innovators to accelerate timelines, reduce risk, and stay ahead in the race to bring life-changing therapies to patients.
