I Peace, Inc., a Palo Alto, CA-based biotech start-up, has 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 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 says it 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 assurance to clients looking to use the company’s iPSCs for clinical and commercial use in the U.S., Japan and other global markets. I Peace is listed on the FDA Drug Establishments Current Registration Site, which helps 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 (APIs); 21 CFR 210/211, U.S. 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, Labor, and Welfare to manufacture specific cell-based products.