Peace Engine Kyoto was granted U.S. cGMP (Current Good Manufacturing Practices) by a third-party certification for its manufacturing facility in Kyoto, Japan. Previously awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare for manufacturing specific cell-based products, the facility now meets manufacturing standards for both the U.S. and Japanese markets. The cGMP pertains to ICH-Q7, 21CFR210/211, and 21CFR1271, and with the certification now enables clients of Peace Engine Kyoto interested in using the induced pluripotent stem cell on a clinical or commercial level across global markets with facing regulatory issues.
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