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$20 million cGMP facility will be located in Wisconsin and plans to open in 2020
January 4, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
Fujifim Cellular Dynamics, Inc. (FCDI), a U.S. subsidiary of Fujifilm Corporation, is investing about $21 million to open a new cGMP-compliant production facility with the goal of industrializing iPS cell manufacturing for regenerative medicine therapies. The Madison, WI facility will support FCDI’s internal cell therapeutics pipeline and will also serve as a contract development and manufacturing organization (CDMO) for iPS cell products. Regenerative medicine is a highly advanced treatment modality with the potential to improve the quality of life for patients. The field is quickly growing due to scientific and engineering advancements that can harness the potential of iPS cells. “To meet the growing demand for FCDI’s iPS cell platform, the state-of-the-art production facility will have a flexible cell culturing design to serve production requirements of both industrial quantities of cells, and small, diverse batches,” said Seimi Satake, chairman and chief executive officer of FCDI. “By combining Fujifilm’s experience gleaned from the intricate process of manufacturing photographic film along with FCDI’s knowledge of cell reprogramming, genetic engineering and cell differentiation, the facility is poised to address the complex manufacturing processes of cell therapies.” With the facility operational by March 2020, FCDI intends to accelerate the development of its internal pipeline to address unmet medical needs in areas such as age-related macular degeneration, retinitis pigmentosa, Parkinson’s disease, heart diseases, and cancer. FCDI will continue to leverage its technologies and knowledge of iPS cells, working together with academic institutions and corporations around the world to advance the field of regenerative medicine with the hope of providing new therapies for patients. A recent milestone achievement in the field includes Fujifilm’s partnership with Cynata Therapeutics Limited for its product candidate CYP-011, which utilized FCDI’s iPS cells, and represents the first-ever time a clinical trial using an iPS cell-derived therapy has been completed. www.FujifilmCDI.com
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