Categories: NewsPharmaceutical

REPROCELL Launches StemEdit – Clinical Gene Editing Services and New iPSC Lines Using AI-Designed editing tools

BELTSVILLE, Md., Jan. 28, 2026 /PRNewswire/ — REPROCELL today announced the commercial launch of StemEdit, its clinical gene editing services and new gene-edited iPSC product lines leveraging OpenCRISPR-1™, an AI-designed genome editing system licensed from Profluent (Emeryville, CA, USA).

StemEdit encompasses REPROCELL’s proprietary clinical gene-editing technology and its new gene-edited iPSC lines that are ready for immediate use. These offerings combine REPROCELL’s StemRNA™ Clinical iPSC Seed Clones, with OpenCRISPR-1™ enabled engineering workflows, ensuring a GMP-aligned, traceable, and regulatory-ready platform from the outset.

OpenCRISPR-1™ is a de novo AI-designed gene editor, created using large language models trained on extensive CRISPR-Cas datasets. Early reports indicate high editing efficiency, reduced off-target activity, and lower predicted immunogenicity in human cells, making this technology well suited for clinical and translational applications.

The new StemEdit services and cell lines are designed to support allogeneic off-the-shelf cell therapy development, offering enhanced targeting flexibility, improved safety profiles, and licensing-friendly alternatives to heavily encumbered CRISPR-Cas systems. Simplifying intellectual property complexity and downstream commercial risk for therapeutic developers will enable rapid adoption. All products and services are delivered under GMP-aligned workflows, with robust quality control and documentation to support efficient clinical translation and global regulatory expectations.

This launch strengthens REPROCELL’s position as a platform partner of choice for biotech and pharmaceutical companies by combining AI-driven gene editing, clinically validated iPSC starting materials, and established manufacturing and regulatory infrastructure into a single, deployable solution.

Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., commented:
“By launching StemEdit and incorporating OpenCRISPR-1™ under an open-source license, we are providing our customers with immediate access to next-generation gene editing technologies built for clinical translation, scalability, and regulatory confidence.”

Rama Modali, CEO of REPROCELL USA Inc., added:
“StemEdit represents a major step forward for teams developing next-generation cell therapies. By combining AI-designed genome editing with our clinically validated StemRNA™ iPSC Seed clones, we’re giving developers a faster, cleaner path from research to the clinic. This platform removes traditional IP and scalability barriers, enabling our partners to focus on what matters most and bringing transformative therapies to patients.”

About REPROCELL
REPROCELL provides integrated stem cell, gene editing, Molecular and Biorepository services supporting programs from discovery through clinical development. Headquartered in Yokohama, Japan, with global operations in the United States, Europe, and Asia, REPROCELL partners with academic, biotech, and pharmaceutical organizations worldwide to advance regenerative medicine and cell therapy development.

For more information, visit www.reprocell.com or contact info-us@reprocellusa.com.

CONTACT: Rama Modali, rmodali@reprocellusa.com

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SOURCE REPROCELL USA

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