REPROCELL and Histocell Achieve GMP Certification for Manufacturing Process of Clinical-Grade iPSC Master and Working Cell Banks Using StemRNA™ Clinical iPSCs
Yokohama, Japan / Bilbao, Spain – October 20th — REPROCELL (Yokohama, Japan; TYO: 4978) and Histocell (Bilbao, Spain) are proud to announce that the Spanish Agency for Medicines and Medical Devices (AEMPS), operating under European Medicines Agency (EMA) oversight, has granted to Histocell Good Manufacturing Practice (GMP) certificate and authorization of the manufacturing process of induced Pluripotent Stem Cell (iPSC) Master Cell Banks (MCB) and Working Cell Banks (WCB) generated using REPROCELL’s proprietary StemRNA™ Clinical iPSCs at Histocell’s manufacturing facility.
This certification represents a significant milestone in the partnership between REPROCELL and Histocell, advancing their shared mission to enable the safe, compliant, and scalable manufacturing of clinical-grade iPSCs and derived cell therapies for global applications. The GMP MCBs and WCBs are designed to meet EMA requirements as well as international regulatory standards, enabling sponsors to use these cell banks for clinical development and commercialization in multiple global markets.
Strengthening Europe’s Advanced Cell Therapy Manufacturing Capabilities
Histocell’s 800 m² GMP manufacturing facility is authorized by AEMPS under EMA oversight for the GMP production of cell therapy and derived biological medicinal products (secretome). Equipped with seven clean rooms, a dedicated cell banking suite, Fill & Finish room, and integrated QC laboratories, the facility supports production of both pilot and full-scale clinical-grade batches for use in all clinical phases (I-III) and for global regulatory submissions.
The new certification enables the manufacture of StemRNA™ Clinical iPSC-derived MCBs and WCBs under EU GMP conditions, bridging preclinical and clinical development and paving the way toward industrial-scale production.
An Integrated Platform from Discovery to Clinical Translation
REPROCELL’s proprietary StemRNA™ reprogramming technology enables the generation of clinical-grade, footprint-free iPSCs under defined, xeno-free conditions in compliance with global regulatory standards (FDA, EMA, PMDA). Together with Histocell’s two decades of GMP experience and CDMO capabilities, the partnership offers sponsors a seamless, end-to-end solution, from donor sourcing and iPSC generation to GMP MCB and WCB production, supported by robust quality systems and regulatory expertise.
Histocell’s AEMPS manufacturing authorization (MIA Reference 1174, Laboratory Authorization No. 4269E) allows it to provide GMP services to national and international partners, including REPROCELL’s customers in Europe, Japan, and beyond. This collaboration strengthens Europe’s position as a hub for next-generation regenerative medicine manufacturing and accelerates the translation of iPSC-based therapies toward clinical and commercial applications globally.
About REPROCELL
REPROCELL (Yokohama, Japan; TYO: 4978) supports scientists worldwide through stem cell and drug discovery services and products. Since its founding in 2003 by leading Japanese stem cell researchers, REPROCELL has provided technologies that support prize-winning research and enable new cell therapy development to improve human health. To find out more, visit www.reprocell.com or contact info-us@reprocellusa.com.
About Histocell
Histocell (Bilbao, Spain), is a biopharmaceutical company specialized in Regenerative Medicine, developing and GMP manufacturing of advanced cell therapies, secretomes, and tissue regeneration products. With over 20 years of experience, Histocell provides CDMO services supporting clients from process development through GMP and industrial-scale manufacturing. To find out more, visit www.histocell.com.