#USA #GMP #iPSC #REPROCELL #Beltsville, MD

REPROCELL Launches New GMP Master Cell Bank for Clinical iPSCs

On March 3, 2026, REPROCELL (TYO: 4978) announced a significant advancement in the realm of regenerative medicine with the launch of its Good Manufacturing Practice (GMP) compliant Master Cell Bank (MCB). This initiative, based in Beltsville, Maryland, establishes a comprehensive workflow for clinical manufacturing of induced pluripotent stem cells (iPSCs).

A Comprehensive Service for iPSC Manufacturing

REPROCELL's latest offering not only includes the production of clinical StemRNA™ iPSC Seed Clones but also integrates StemEdit gene editing services into a unified process. This end-to-end solution aims to facilitate developers of cell therapies in accelerating their applications for Investigational New Drug (IND) submissions while minimizing risks associated with regulatory compliance and manufacturing complexities.

As part of this innovative platform, the StemRNA Clinical iPSC Seed Clone - LLF-34-F3 is derived from US donor material and is backed by a current FDA Drug Master File (DMF). This specific clone has been expanded into a GMP-MCB that utilizes FDA-compliant closed system processes. As a result, this clinical-grade iPSC Master Cell Bank is now available for commercial use, offering ready-to-use, clinically validated raw materials.

For those sponsors looking to align their projects with European standards, REPROCELL has partnered with Histocell to provide MCB/WCB production under a GMP certificate that has been approved by the Spanish Agency for Medicines and Health Products (AEMPS) and is under the auspices of the European Medicines Agency (EMA).

Key Features of Clinical iPSC Services

• - Donor Procurement and Eligibility: Adheres to FDA, EMA, and PMDA requirements for therapeutic use.
• - Footprint-free proprietary RNA Reprogramming: Generation of StemRNA™ Clinical iPSC Seed Clones meets regulatory standards.
• - Clinical Seed Clones Production: Created in the USA supported by an active FDA DMF.
• - Genetic Integrity Assessments: Oncogenic risk evaluations through whole-genome sequencing (WGS) for clinical Seed Clones.
• - StemEdit Gene Editing Services: Focuses on high efficiency with reduced off-target activity and minimized anticipated immunogenicity.
• - Compliance in GMP-MCB Production: Offered in alignment with FDA or EMA and PMDA manufacturing authorizations.

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

The StemRNA™ Clinical iPSC Seed Clone - LLF-34-F3 originates from a healthy female O+ US donor. This clone is fully permitted for both commercial and therapeutic use, homozygous at the HLA-A and HLA-DPA1 loci, thereby increasing its potential for allogeneic applications. The Seed Clone meets the stringent criteria established by the FDA, EMA, and PMDA while being supported by a DMF, assuring that the GMP expansion of the Master Cell Bank employs processes that yield traceable, clinically viable raw materials.

Moreover, REPROCELL provides options for StemRNA™ Clinical iPSC Seed Clones from various donor profiles, catering to diverse therapeutic needs.

Commitment to Cell Therapy Development

Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., expressed excitement regarding the company's new offerings. He stated, “We are thrilled to provide cell therapy developers with a streamlined pathway for clinical program development, completing the clinical iPSC workflow from donor screening, seed iPSC production, StemEdit gene editing, and GMP banking in a coordinated framework. This integrated platform is designed to expedite IND/CTA submissions while ensuring quality, traceability, and global regulatory compliance.”

About REPROCELL

REPROCELL is at the forefront of integrated stem cell, gene editing, and GMP production solutions that guide projects from discovery to clinical application. Through the production of clinically qualified iPSCs (StemRNA™ Clinical iPSC), StemEdit gene editing, and GMP banking capabilities, REPROCELL is committed to serving academic, biotech, and pharmaceutical organizations seeking reliable, regulatory-ready cell starting materials and services.

This initiative has received support through a commercialization grant (No. 2024-MSCRFCO-6418) from the Maryland Stem Cell Research Fund (MSCRF).

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