Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that its Palo Alto quality control testing facility has been accredited as ISO 17025: 2017 compliant. The accreditation was certified by ANSI National Accreditation Board, one of the leading accreditation bodies in the world. The tests in the scope of accreditation center on the characterization of iPSCs and include cell count and viability per USP <1046>, detection of pluripotency marker expression by flow cytometry per USP <1027>, and also by immunofluorescence assay. I Peace has also been accredited for a quantitative real-time PCR method to detect residual Sendai virus vectors in the reprogrammed cells. The current ISO accreditation at the I Peace Palo Alto facility shows that our quality control testing is carried out at a high standard. I Peace cell manufacturing facility in Kyoto, Japan has been certified as compliant with US FDA cGMP 21 CFR 211 and 1271, and ICH Q7, and licensed by the Japanese government to manufacture specific cell products, suggesting that its quality management system meets the industry’s highest standards both in manufacturing and quality control testing of the manufactured cell products.
With this ISO accreditation, I Peace started undertaking quality evaluation and characterization of iPSCs for its existing customers as well as other companies and research institutions in the cell therapy industry.
What it means to our clients
ISO 17025 is a quality management system standard for testing and calibrations and I Peace has gone through careful planning, analysis, training, and quality management system construction and implementation before going through the third-party audit. Our clients can be assured that, at I Peace, flow cytometry, immunofluorescence assay, residual Sendai virus vector detection, and viability testing are conducted under procedures that meet rigorous ISO standards. The tests were developed and validated to qualify for accreditation. To obtain and maintain the accreditation, I Peace is responsible for maintaining a robust quality management system, participating in proficiency testing, using reference standards where possible, and undergoing an annual audit by the accrediting body.
I Peace is committed to providing high-quality cell products to its clients by regularly reviewing its processes and traceability, and training its staff members to maintain and constantly improve its product quality.