ReproCELL

REPROCELL Launches FDA-Compliant GMP Manufacturing Platform for Clinical iPSCs

- REPROCELL has launched a comprehensive GMP Master Cell Bank manufacturing service for clinical-grade induced pluripotent stem cells from its Maryland facility, offering end-to-end workflow capabilities. - The platform includes the StemRNA Clinical iPSC Seed Clone LLF-34-F3, derived from US donor material and supported by an active FDA Drug Master File. - The integrated service spans donor screening, iPSC manufacturing, gene editing, and GMP banking to accelerate IND submissions for cell therapy developers. - REPROCELL also provides European manufacturing alignment through partner Histocell, operating under EMA oversight and Spanish regulatory authorization.