FUJIFILM Cellular Dynamics to Establish New Facility for Production of Human iPS Cell Therapy Applications

FUJIFILM Cellular Dynamics, Inc. (FCDI), a US subsidiary of FUJIFILM Corporation (President: Kenji Sukeno) and a leading global developer and manufacturer of human induced pluripotent stem (iPS) cell technologies, has announced an investment of about $21 million to open a new cGMP-compliant*1 production facility with the goal of industrializing iPS cell manufacturing for regenerative medicine therapies. The 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.

To fulfill the promise of cell therapy, sophisticated techniques and expertise are required to culture, differentiate, and control the quality of cells. Fujifilm has broad expertise across the regenerative medicine field through its group companies including Japan Tissue Engineering Co., Ltd., FUJIFILM Wako Pure Chemical Corporation, and FUJIFILM Irvine Scientific, Inc.

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*2 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.

In addition to its advancements in regenerative medicine, FCDI manufactures iPS cell products for public institutions, major pharmaceutical companies, and academia for the purpose of life science research.

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