REPROCELL announced the launch of its US FDA compliant Good Manufacturing Practice (GMP) Master Cell Bank (MCB) manufacturing service for human induced pluripotent stem cells (iPSCs). Operating from its Beltsville, Maryland facility, REPROCELL now offers a comprehensive, end-to-end workflow for clinical iPSC manufacturing. This integrated service spans from StemRNA™ clinical seed iPSC manufacturing and StemEdit gene editing to GMP Master Cell Bank (MCB) production in compliance with FDA standards. By unifying these critical steps, REPROCELL enables cell therapy developers to accelerate IND submissions while reducing regulatory and manufacturing uncertainty.
As part of this platform, the StemRNA Clinical iPSC Seed Clone – LLF-34-F3, derived from US sourced donor material, is supported by an active FDA Drug Master File (DMF). This clone has been expanded into a GMP MCB using FDA-compliant closed system processes. This off-the-shelf GMP iPSC MCB is now available for commercial use, providing ready-to-use clinically validated starting material. For sponsors requiring European alignment, REPROCELL also offers MCB/WCB manufacturing through its partner, Histocell. This service operates with a GMP certificate and authorization from the Spanish Agency for Medicines and Medical Devices (AEMPS) under European Medicines Agency (EMA) oversight.
Key Highlights: Clinical iPSC Capabilities
- Donor sourcing and eligibility meet FDA, EMA, and PMDA requirements with full consent for therapeutic use.
- Footprint-free proprietary RNA reprogramming to generate StemRNA™ Clinical iPSC Seed Clones under FDA/EMA/PMDA requirements.
- US-generated StemRNA Clinical Seed Clones supported by an active FDA DMF
- Genetic integrity and oncogenic risk assessment using whole-genome sequencing (WGS) for StemRNA Clinical Seed Clones
- StemEdit clinical gene editing service, engineered for high on target efficiency with reduced off target activity and lower predicted immunogenicity
- GMP MCB manufacturing in compliance with FDA or under EMA and PMDA authorization to manufacture