(Palo Alto, California) I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-wining technology “induced pluripotent stem cell (iPSC)” began manufacturing clinical-grade iPSCs.
We are now officially taking orders for custom manufacturing of clinical-grade iPSCs from institutions around the world.
On March 11, 2020, the company received a license to manufacture clinical-grade cells from Japan’s Ministry of Health, Labour and Welfare for its cell manufacturing facility located in Kyoto, Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) audited I Peace’s GMP facility Peace Engine-Kyoto and reviewed facility operation, sanitization, cell culturing, Quality Control, and maintenance standard operating procedures (SOPs) among others as part of the approval process to manufacture clinical-grade cells.
Leveraging deep regulatory expertise across both the United States and Japan along with a strong intellectual property position, I Peace is now manufacturing clinical-grade iPSC lines and has officially started to serve as a contract development and manufacturing organization for clinical-grade iPSCs. While the iPSCs are manufactured in Japan, the cells can be shipped globally.
I Peace plans to further expand production capacity by building a system capable of manufacturing thousands of clinical-grade iPSCs annually using our automated technology.
iPSCs are adult cells that are reprogrammed to an embryonic stem cell-like state by introducing special factors (genes). iPSCs are able to become any type of cells in the body and proliferate almost indefinitely, like an embryonic stem cell. Unlike embryonic stem cells, iPSCs can be made from mature cells in the body, such as skin or blood cells, from anyone. iPSC-derived cell therapy generated from a patient’s own cells minimizes the risk of immune rejection and is expected to change the course of regenerative medicine, drug discovery, and personalized medicine.
Background of Obtaining the Manufacturing License
Demand for clinical-grade iPSCs has surged in the past two 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. In Japan, facilities that produce clinical-grade iPSCs for cell therapy must comply with the Act on the Safety of Regenerative Medicine.
With the license from the Ministry of Health, Labour, and Welfare, we are now officially able to serve as a contract manufacturer of clinical-grade iPSCs. We will expand accessibility and availability of clinical-grade iPSC lines so clinical research institutions can select the most appropriate iPSC line for each of their specific clinical research, taking into account differentiation propensity and other factors.
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 fully-closed automated iPSC manufacturing system and it meets the safety standards set by the Japanese Act on the Safety of Regenerative Medicine.