Friday, 02 June 2023

Japan's REPROCELL to boost its GMP iPSC - Master Cell Bank (MCB) manufacturing service

02 September 2021 | News

Signs strategic collaboration agreement with TEXCELL to boost GMP iPSC master cell bank manufacturing capability

Photo Credit: Freepik

Photo Credit: Freepik

REPROCELL has signed a strategic collaboration agreement with TEXCELL JAPAN, a TEXCELL Group Company, for GMP iPSC - Master Cell Banks (MCB) Manufacturing. The TEXCELL Group 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 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. 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 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."

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