Key Challenges in Clinical iPSC Applications: How REPROCELL Helps You Succeed

Blogs

1. Ethical and Regulatory Compliance The challenge: Clinical and commercial applications require strict ethical oversight and compliance with global regulatory standards. Our solution: REPROCELL follows IRB-approved informed consent protocols, and the clinical iPSC generation is compliant with all major regulatory standards (FDA, EMA, PMDA). We ensure: Full donor de-identification Ethical donor recruitment Global consent for clinical and…

REPROCELL and Histocell have achieved GMP certification for their manufacturing process of clinical-grade iPSC master and working cell banks using StemRNA™ Clinical iPSCs, ensuring high-quality and safe production for regenerative medicine applications.

Corporate News

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…