02 November 2022 | Wednesday | News
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I Peace has been providing GMP Induced Pluripotent Stem Cells (iPSC) for a variety of cell therapy developers and pharmaceutical companies in the past several years and we believe this wonderful partnership with CIRM reflects the high-quality of our cell products and accompanying services.
I Peace is providing access to excellent quality, well-characterized iPSC lines via I Peace's proprietary technologies and profound iPSC expertise, I Peace is offering research-grade iPSCs derived from GMP iPSCs to CIRM's Discovery pursuit stage research projects for product development in regenerative medicine. CIRM awardees will also have access to I Peace GMP manufacturing services for CIRM Translational and Clinical Stage projects.
Supported by $5.5 billion in funding from the state of California, CIRM has funded 82 clinical trials and is backing more than 152 active regenerative medicine research projects spanning candidate discovery through phase III clinical trials.
The I Peace cell manufacturing 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 provides 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.