I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based GMP cell manufacturing CDMO and personal iPSC banking provider, announced that the company has succeeded in developing a propriety automated iPSC high-throughput induction system to induce thousands of iPSC lines simultaneously. There are various automated cell processing/expansion systems in the market today, but this is the first high-throughput, automated cell processing system that is capable of inducing iPSCs from somatic cells.
I Peace founder and CEO Koji Tanabe will present this automated iPSC high-throughput induction system at the upcoming ISSCR 2022 Annual Meeting of the International Society for Stem Cell Research. This system can be used to induce thousands of iPSC lines simultaneously. He will be joined by Stanford University professor Dr. Marius Wernig who will discuss the future of autologous iPSC cell therapy. The space-saving automated cell induction/manufacturing unit will be displayed on site at the ISSCR 2022 Annual Meeting.
The current industry trend favors allogeneic iPSC-based cell therapy, and I Peace is a leading CDMO in the space providing iPSC-derived cell products for many allogeneic cell therapy developers. However, a key benefit of iPSCs is that iPSCs can be generated from anyone, enabling autologous cell therapy. To maximize this advantage of iPSCs, I Peace has begun a personal iPSC banking service. I Peace aims to be the bridge between individuals in need of iPSC-derived cell therapy and cell therapy providers by connecting patients to appropriate therapies and, upon consent from personal iPSC banking clients, a large database of iPSCs available for cell therapy research and development. This is part of I Peace’s endeavor to realize a world in which everyone has their own iPSCs and certain iPSC-derived cell products for potential medical use when needed.
With its FDA-registered cell manufacturing facility, I Peace has been manufacturing GMP iPSCs master cell banks, working cell banks, and iPSC-induced cell products for pharmaceutical companies and cell therapy developers. The company has recently tripled its capacity to manufacture GMP-grade iPSCs and iPSC-derived differentiated cells by expanding its facility. With this expansion, I Peace is now responding to the growing needs for GMP iPSCs from pharmaceutical companies and cell therapy developers, as well as individuals looking to bank their own iPSCs.
The facility is certified as GMP compliant and listed on the FDA “Drug Establishments Current Registration Site.” The certification recognizes I Peace’s cell manufacturing facility as suitable for drug manufacturing, based on a detailed audit. 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 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 and the FDA track the facility for inspections in the process of obtaining information for FDA approval of the iPSC-derived cell products.
The new automation technology, combined with the regulatory and manufacturing know-how I Peace already has, will usher a new era of autologous iPSC-derived cell therapies.