Yokohama Japan, 18 August 2021: REPROCELL have signed a Master Service Agreement with TEXCELL JAPAN a TEXCELL Group Company for GMP iPSC - Master Cell Banks (MCB) Manufacturing. The TEXCELL Group (hereinafter “TEXCELL”) is a contract manufacturing organization (CMO) headquartered in France and managed by the holding company Soparbiotech International.
In recent years, the movement towards clinical application of iPSCs has been active in the US, Europe, and Japan. In these locations, there is now increasing demand for GMP iPSC MCBs that can be used for therapeutic applications.
REPROCELL has established a manufacturing pipeline for GMP iPSC MCBs in accordance with the guidelines of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. By signing this Master Service Agreement, REPROCELL can now outsource part of the MCB manufacturing process at TEXCELL's GMP facility, certified by EMA, enabling the establishment of GMP iPSC MCB.
“As the therapeutic application of iPSCs accelerates around the world, the requirement of high-quality GMP iPSC will surge,” said Chikafumi Yokoyama, Chairman and CEO REPROCELL. “As the leader in iPSC research, we can now produce GMP iPSC MCB to meet the demand of our clients with strict compliance with key regulatory agencies,” he continued.
You can find out more about REPROCELL’s GMP iPSC Master Cell Bank service on our website.
About TEXCELL: Established in 1987, TEXCELL provides contract services for viral clearances, viral safety testing and the manufacture of GMP cell banks (Master and Working cell bank) – in accordance with the guidelines of the FDA, EMA, and PMDA verified by regular inspection (inspected by FDA and EMA) – to pharmaceutical companies and bioventures in Europe, the US, and Asia as a CMO. For more information visit the TEXCELL website: www.texcell.com