Integrated Workflow Including Clinical Seed Production and StemEdit Gene Editing Services

Beltsville, MD, USA / Yokohama, Japan – 3rd March 2026

Bioserve – A REPROCELL Company proudly announces the launch of US FDA-compliant Good Manufacturing Practice (GMP) Master Cell Bank (MCB) manufacturing services for human induced pluripotent stem cells (iPSCs), now available to support global cell therapy developers, including partners in India.

Through REPROCELL’s state-of-the-art facility in Beltsville, Maryland, a comprehensive end-to-end clinical iPSC manufacturing workflow is now operational. This integrated platform spans:

  • StemRNA™ Clinical iPSC Seed Manufacturing

  • StemEdit Clinical Gene Editing Services

  • GMP Master Cell Bank (MCB) Production compliant with US FDA standards

By unifying these critical development stages under a coordinated framework, Bioserve and REPROCELL enable biotechnology and pharmaceutical organizations to accelerate IND submissions while minimizing regulatory and manufacturing risks.

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 a 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 compliant with FDA, EMA, and PMDA regulatory requirements, with full therapeutic consent

  • Footprint-free proprietary RNA reprogramming technology to generate StemRNA™ Clinical iPSC Seed Clones

  • US-generated StemRNA™ Clinical Seed Clones supported by an active FDA DMF

  • Comprehensive genetic integrity and oncogenic risk assessment using whole-genome sequencing (WGS)

  • StemEdit clinical gene editing service engineered for high on-target efficiency, reduced off-target activity, and lower predicted immunogenicity

  • GMP Master Cell Bank manufacturing in compliance with US FDA standards or under EMA authorization

About StemRNA™ Clinical iPSC Seed Clone – LLF-34-F3

StemRNA™ Clinical iPSC Seed Clone – LLF-34-F3 is derived from a healthy O+ female US donor, fully consented for commercial and therapeutic use. The clone is homozygous at HLA-A and HLA-DPA1 loci, enhancing its suitability for allogeneic applications.

The seed clone meets FDA, EMA, and PMDA standards and is supported by a Drug Master File (DMF). GMP Master Cell Bank expansion follows FDA-compliant processes, ensuring traceability, quality, and clinical readiness.

Additional StemRNA™ Clinical iPSC Seed Clones from diverse donor profiles are also available to meet specific therapeutic program requirements.

Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., commented:
“By completing clinical iPSC workflow starting from donor screening, seed iPSC manufacturing, StemEdit clinical gene editing, and GMP cell banking under one coordinated framework, we are delighted to provide cell therapy developers a streamlined path for clinical program development. This integrated platform is designed to accelerate IND/CTA submissions while preserving quality, traceability, and global regulatory alignment.”

About REPROCELL
REPROCELL provides integrated stem cell, gene editing, and GMP manufacturing solutions supporting the entire path from discovery to clinical translation. With clinical grade iPSC generation (StemRNA™ Clinical iPSC), StemEdit clinical gene editing, and GMP banking capability, REPROCELL serves academic, biotech, and pharmaceutical organizations seeking reliable, regulatory ready cell starting materials and services.

This work was supported by a Commercialization Grant (no. 2024-MSCRFCO-6418) from the Maryland Stem Cell Research Fund (MSCRF)