(Palo Alto, California) I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-winning technology “induced pluripotent stem cells (iPSCs)” received a third-party certification as US FDA cGMP compliant for its manufacturing facility “Peace Engine Kyoto,” in Kyoto Japan. Peace Engine Kyoto is owned and managed by its sole subsidiary I Peace, Co. Ltd. The facility was awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare to manufacture specific cell-based products.

The current GMP certification pertains to: ICH-Q7, a global guideline for the manufacturing of active pharmaceutical ingredients; 21CFR210/211, US regulations for manufacturing, processing, packing, or holding of drugs, and for finished pharmaceuticals and; 21CFR1271, US regulations for human cell and tissue products. The certification provides peace of mind to client organizations looking to use our iPSCs clinically and commercially in the US, Japan, and global markets for regulatory issues.

We previously obtained independent IRB (US) approval for its processes, and privacy mark certification (Japan) for handling private information of donor, establishing a robust system to ensure traceability and protection of our client organizations. With our off-the-shelf and custom GMP iPSC manufacturing services, I Peace is committed to contribute to the further development of regenerative medicine and drug discovery by serving a broader customer base including research institutions, medical institutions, and pharmaceutical companies.

Key Takeaways

• I Peace manufacturing facility (Peace Engine Kyoto) and its quality management system received a third-party certification as compliant with ICH-Q7, 21 CFR 210/211, and 21 CFR 1271.
• I Peace provides multiple off-the-shelf clinical-grade iPSC lines meeting both U.S. and Japan GMP standards.
• I Peace custom manufactures clinical-grade iPSC lines meeting both U.S. and Japan GMP standards.
• Peace Engine Kyoto:
  • Meets global guideline ICHQ7 as stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
  • Meets US FDA regulation 21 CFR 210/211
  • Is licensed by Japan’s Ministry of Health, Labour and Welfare to manufacture specific cell-based products as stipulated by the “Act on the Safety of Regenerative Medicine”
• Quality Management System:
  • Adheres to rigorous procedure in creating and maintaining batch records
  • Guarantees traceability of every test reagent and materials used
  • Meets US FDA regulation 21 CFR 1271
• Approved by an independent IRB (U.S.) regarding a set of donor-related procedures including informed consent

Significance of Obtaining the U.S. FDA GMP certification
iPSCs must be differentiated before transplantation for cell therapy, and as an intermediate, iPSC manufacturing facilities and its process/quality control 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 of iPSCs becomes subject to FDA review. Since iPSCs are a key intermediate in the cell therapy manufacturing process, iPSC manufacturing process and quality management system compliance to GMP has an outsized impact on the regulatory approval of the cell therapy.

With the U.S. FDA GMP certification of I Peace’s manufacturing facility, Peace Engine Kyoto, our clients can use our iPSCs with confidence for clinical application and drug development. Furthermore, our clients can benefit from a huge savings in time and cost when applying for regulatory approval in both the U.S. and Japan as they can use the same iPSC line for both markets.

Significance of offering multiple clinical-grade iPSC lines off-the-shelf
Demand for clinical-grade iPSCs has surged in the past few years with various iPSC-derived cells entering clinical trials across the world. However, there are very few facilities worldwide that can manufacture clinical-grade iPSCs. On top of that, variability in differentiation propensity has been an issue for developing clinical cell therapy. By providing multiple clinical-grade iPSC lines, I Peace allows research and clinical institutions to choose the iPSC line best suited for their differentiation protocol, accelerating their research.

One of our strengths lies in our core proprietary technology which enables mass production of distinct clinical-grade iPSC lines simultaneously in a single room, using a miniaturized plate aided by robotic technology. Our facility is equipped with a fully-closed automated iPSC manufacturing system and it meets the safety standards set by the regulatory bodies in the U.S. and Japan.

Envisioning a world where iPSCs are accessible to all, I Peace, Inc. will continue to develop innovative technologies to accelerate therapeutic applications of iPSCs.

Cellular differentiation propensity: ES/iPSC lines differ in their propensity to differentiate into a certain types of cells. Research efficiency can be improved by having multiple lines of ES/iPSCs and choosing the one that best fits the purpose of the clinical research.