YOKOHAMA, Japan, Sept. 2, 2021 /PRNewswire/ — REPROCELL have signed a Strategic Collaboration 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, the US, and Japan. In these locations there is now increasing demand for GMP iPSC MCBs that can be used for therapeutic applications.
REPROCELL has established 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. REPROCELL can outsource part of the MCB manufacturing process at TEXCELL’s GMP facility, certified by EMA, enabling the establishment of GMP iPSC MCB.
This Strategic Collaboration Agreement supplements the earlier signed Master Service Agreement and strengthens the relationship with TEXCELL as a strategic partner in generating GMP iPSC – Master Cell Bank for REPROCELL clients globally.
“The partnership with TEXCELL will boost our GMP iPSC master cell bank manufacturing capability,” said Daisuke Usui, Chief Operating Officer REPROCELL. “TEXCELL has an extensive expertise and robust track record in GMP cell bank manufacturing in compliance with the FDA, EMA and PMDA. TEXCELL’s capability, together with REPROCELL’s RNA reprogramming stem cell technology, is a great fit for the company’s GMP iPSC offerings.”
You can find out more about REPROCELL’s GMP iPSC MCB 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 ANSM for EMA) – to pharmaceutical companies and bioventures in Europe, the US, and Asia as a CMO. For more information visit the TEXCELL website or LinkedIn page.