(Palo Alto, California) I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up, announced that the company had tripled its capacity to manufacture GMP grade iPS cells and iPSC-derived differentiated cells by expanding its facility. The facility’s expansion, designed to conform to GMP standard, is now almost complete and is expected to start manufacturing cGMP grade cells in April this year after going through a regulatory review and FDA registration update. With this CDMO facility expansion, I Peace will be able to meet the growing needs for GMP iPS cells from pharmaceutical companies and cell therapy developers, and better serve individuals with increased personal iPS cell banking service capacity.
The facility is certified as cGMP compliant and listed on the FDA “Drug Establishments Current Registration Site.” The registration recognizes I Peace’s cell manufacturing facility as suitable for drug manufacturing, based on detailed information submitted to the FDA. Comprehensive details of clinical-grade iPSC manufacturing are registered in the FDA Drug Master File (DMF). The facility registration, along with DMF registration and GMP certification provide peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets. I Peace’s listing on the FDA Drug Establishments Current Registration Site helps our clients obtain information for FDA approval by simply referencing the FDA Establishment Identifier (FEI).
The current facility was certified by a third-party as GMP compliant, and the current GMP certification pertains to: ICH-Q7, a global guideline for the manufacturing of active pharmaceutical ingredients; 21 CFR 210/211, US regulations for manufacturing, processing, packing, or holding of drugs, and for finished pharmaceuticals and; 21 CFR 1271, US regulations for human cell and tissue products. The facility was also awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare to manufacture specific cell-based products.
The current manufacturing capacity enhancement enables I Peace to meet the growing demand for GMP grade iPSCs and iPSC-derived differentiated cells and support pharmaceutical companies and research institutions that are making efforts to transform cell therapies from tomorrow’s dream to today’s reality.
I Peace’s cell manufacturing facility “Peace Engine Kyoto” receives third-party certification as US cGMP compliant: the facility now meets the standard for both the US and Japanese markets