REPROCELL Inc. and CIRM sign MOU for special access to clinical iPSCs
5 October 2022
Yokohama Japan, 5 October 2022: REPROCELL Inc. has agreed to join the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to make accessible REPROCELL’s unique induced Pluripotent Stem Cells (iPSCs) technology to CIRM Awardees.
REPROCELL has been one of the leaders in the stem cell field since its industry-first commercialization of iPSC-derived cardiomyocytes in 2009 and has quickly expanded its business capabilities through a series of acquisitions. These acquisitions have created a workflow that is critical for developing iPSCs, including human tissue acquisition (Bioserve) and RNA reprogramming technologies to generate iPSCs (Stemgent). Currently, REPROCELL manufactures iPSCs that are suitable for therapeutic use and compliant with the key regulatory standards stipulated by the US FDA, European EMA, and Japanese PMDA. These seed iPSCs (StemRNA™ Clinical iPSC Seed Clones) have been evaluated, approved, and employed by numerous biopharma clients today. This new partnership will accelerate global stem cell-related business using REPROCELL’s StemRNA™ Clinical iPSC Seed Clones.
“We are excited about the opportunity to partner with CIRM and its grantees to support projects in the regenerative medicine field focusing on cell-based therapies using our StemRNA Clinical iPSC Clones” said Chikafumi Yokoyama Ph.D, CEO of REPROCELL Inc.
“CIRM launched the Industry Resource Partner program to create a force-multiplier effect by bringing in industry partners who have the resources, experience and expertise to help further accelerate CIRM-funded regenerative medicine research projects”, says Shyam Patel, Ph.D., Senior Director of Business Development & Alliance Management at CIRM. “By agreeing to provide access to its clinical iPSC clones, Reprocell joins our collaborative network of partners dedicated to advancing transformative regenerative medicine therapies for patients.”
About REPROCELL’s iPSC generation suitable for therapeutic programs Developing cellular therapies is a time-consuming and costly process. It requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. REPROCELL manufactures GMP iPSC MCBs that are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA.
Through our clinical network, we can procure the tissues needed for the therapeutic program and perform the necessary viral and donor profile screenings compliant with key regulatory agencies. After deriving a primary fibroblast primary culture, we use our proprietary footprint-free RNA reprogramming technology to generate a clinical grade iPSC seed stock (StemRNA™ Clinical iPSC Seed Clones). Under strict quality control measures, these StemRNA™ Clinical iPSC Seed Clones are expanded in a GMP environment to manufacture a master cell bank. REPROCELL’s GMP iPSCs are suitable for commercial and therapeutic programs, subject to a simple one-time commercial and therapeutic license without any limitation of therapeutic fields.
About CIRM At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.
To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.
With $5.5 billion in funding and more than 161 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality.