#USA #Beltsville #iPSC #REPROCELL #StemRNA

REPROCELL Unveils Master Cell Bank for Clinical iPSCs

On March 3, 2026, REPROCELL (TYO: 4978) announced the launch of its innovative service focusing on the production of induced pluripotent stem cells (iPSCs) within a Good Manufacturing Practice (GMP)-compliant Master Cell Bank (MCB). This significant development takes place at their facility in Beltsville, Maryland, where the company now offers a comprehensive workflow tailored for clinical-grade iPSCs.

REPROCELL's integrated service includes the manufacturing of StemRNA™ clinical-grade iPSC seeds alongside the StemEdit genomic editing services, ultimately culminating in the establishment of a GMP-compliant Master Cell Bank. By unifying these critical steps, REPROCELL empowers cell therapy developers to expedite their Investigational New Drug (IND) applications while alleviating prevailing regulatory and manufacturing uncertainties.

The featured clinical seed clone, iPSC StemRNA – LLF-34-F3, is derived from a healthy U.S. donor and is supported by an active Drug Master File (DMF) registered with the FDA. This clone has been transitioned into a GMP-compliant MCB utilizing closed-loop processes meeting FDA standards. Consequently, the GMP-compliant iPSC MCB is now commercially available, offering validated clinical-grade starting material that is ready for immediate use. For those sponsors seeking compliance within European markets, REPROCELL can also provide MCB/WCB manufacturing through their partnership with Histocell, a service certified under GMP and authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS), operating under the supervision of the European Medicines Agency (EMA).

Key Features of iPSC Clinical Capabilities

• - Donor Source and Eligibility: The donor’s origin and eligibility are in full compliance with the requirements of the FDA, EMA, and PMDA, supported by complete consent for therapeutic use.
• - Proprietary Reprogramming: The StemRNA technology is employed to generate clinical seed clones of iPSC, aligning with FDA, EMA, and PMDA standards through a non-integrative method.
• - Robust Regulatory Framework: The StemRNA clinical seed clones are populated in the U.S. and are backed by an active DMF submitted to the FDA.
• - Genetic Integrity Assurance: Comprehensive risk assessment for oncogenicity is conducted using whole-genome sequencing (WGS) for StemRNA clinical seed clones.
• - Genomic Editing Services: The StemEdit genomic editing service is designed for precise targeting with reduced off-target activity and anticipated lower immunogenicity.
• - GMP-Compliant MCB Manufacturing: Production is carried out under GMP protocols in adherence to regulatory standards from the FDA and EMA/PMDA authorization.

About the StemRNA™ Clinical Seed Clone LLF-34-F3

The StemRNA clinical seed clone LLF-34-F3 is sourced from a healthy U.S. donor with O+ blood type, who has granted full consent for commercial and therapeutic use. This clone is homozygous at the HLA-A and HLA-DPA1 loci, enhancing its potential for allogeneic applications. It meets FDA, EMA, and PMDA standards and is supported by an active DMF, while the GMP-compliant MCB production follows FDA-compliant methodologies, providing traceable and clinically ready starting material.

REPROCELL also offers options for developing StemRNA clinical seed clones from various donor profiles, catering to a wide range of research needs.

Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., remarked, “By integrating the clinical iPSC workflow from donor selection through to iPSC seed manufacturing, StemEdit genomic editing, and GMP-compliant bank production within a single operational framework, we are excited to simplify the path for cell therapy developers in their clinical program developments. This integrated platform is designed to expedite IND/CTA submissions while maintaining global regulatory alignment, quality, and traceability.”

About REPROCELL

REPROCELL is committed to providing integrated solutions for stem cell manufacturing and genomic editing that adhere to Good Manufacturing Practices. Our offerings support the complete journey from discovery to clinical translation. With our clinical-grade iPSCs (StemRNA™), genomic editing systems (StemEdit), and extensive GMP-compliant production capabilities, REPROCELL serves academic, biotechnology, and pharmaceutical organizations seeking reliable, regulatory-compliant starting materials and services.

For further information, please visit www.reprocell.com.