I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up, announced that its cell manufacturing facility is now 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).
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I Peace‘s cell manufacturing facility is owned and managed by its sole subsidiary I Peace, Ltd. The facility was awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare to manufacture specific cell-based products. It is also 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.
Significance of the U.S. FDA Drug Establishments Current Registration Site listing
iPSCs must be differentiated before cell therapy transplantation, and as an intermediate, iPSC manufacturing facilities and their quality control processes are not subject to FDA review on their own. However, when cell therapy developers seek regulatory approval for iPSC-derived cell therapies, the manufacturing process then becomes subject to FDA review. Since iPSCs are a key intermediate in cell therapy manufacturing, the manufacturing process and GMP compliance have an enormous impact on the regulatory approval of cell therapies.
Manufacturing iPSCs in a FDA-registered facility such as Peace Engine Kyoto provides site information necessary for Investigative New Drug Application (IND), New Drug Application (NDA), or Biologics License Application (BLA). Our clients can use our iPSCs with confidence for clinical application and drug development. Combined with our dedication to global GMP regulation compliance, our clients benefit from significant time and cost savings when seeking regulatory approval in both the U.S. and Japan.