FUJIFILM : Cellular Dynamics to establish new production facility for iPS cells for cell therapy.

- Accelerating the practical application of treatments that apply iPS cells towards the early industrialization of regenerative medicine
- Making the high quality and highly efficient production of iPS cells a reality

January 4, 2019
FUJIFILM Cellular Dynamics, Inc.

FUJIFILM Cellular Dynamics, Inc. (FCDI), a US subsidiary of FUJIFILM Corporation (President: Kenji Sukeno) and a leader in the development and manufacture of human induced pluripotent stem (iPS) cells and tissue-specific cells differentiated from iPS cells, will establish a new cGMP-compliant*production facility with an investment of about 21 million US dollars in order to enhance its production of iPS cells for cell therapy. The facility is scheduled to begin operations during fiscal year ending March 2020.
FCDI will use the iPS cells produced at this facility to accelerate development of its regenerative medicine products. In addition, by also conducting contract development and manufacturing of iPS cells and iPS cell-derived differentiated cells, it will expand its business and scale to the industrial stage.

Regenerative medicine is drawing interest as a solution for unmet medical needs. There are high expectations for the practical application of treatments that utilize iPS cells, as these cells possess totipotency and the capacity for infinite reproduction, making it possible to produce a large volume of diverse cells. To fulfill the promise of cell therapy, sophisticated techniques and know-how are required to culture, induce differentiation in, and control the quality of cells.

FCDI will be establishing a new production facility equipped with cell culture facilities appropriate for the production of a large volume of cells, as well as culture facilities appropriate for small-scale, diverse production, and a system capable of highly precise cell quality analyses. By also harnessing world-class technologies for the initialization and induction of differentiation in iPS cells and Fujifilm's advanced engineering technology and image analysis technology, the facility will be capable of efficiently producing high-quality iPS cells.
Going forward, FCDI will use the high-quality iPS cells produced at this facility to accelerate the development of regenerative medicine products in the areas of age-related macular degeneration, retinitis pigmentosa, Parkinson's disease, heart diseases, and cancer. FCDI will also contribute to the realization and spread of treatments that utilize iPS cells by widely conducting the contract development and manufacturing of iPS cells and iPS cell-derived differentiated cells.

Currently, FCDI provides iPS cells and iPS cell-derived differentiated cells to public institutions, major pharmaceutical companies, and academia including the California Institute for Regenerative Medicine**and the National Heart, Lung, and Blood Institute***while accelerating the development of its regenerative medicine products. FCDI will continue to harness its accumulated data, technologies, and know-how related to iPS cells, working together with academic institutions and corporations around the world and utilize the technologies and know-how of Fujifilm group companies including Fujifilm, Japan Tissue Engineering Co., Ltd., FUJIFILM Wako Pure Chemical Corporation, and Irvine Scientific Sales Company, Inc. to further expand its iPS cell-based business and contribute to the elevation of regenerative medicine business to the industrial stage.

■ Overview of the New Facility

Location	Madison, Wisconsin, US
Products	iPS cells and iPS cell-derived differentiated cells
Major facilities	cGMP-compliant cell culture facilities for large cell volumes, cell culture facilities for small cell volumes, cell quality evaluation system, contract development laboratory, etc.
Start of operation	Fiscal year ending March 2020

• *An abbreviation of current Good Manufacturing Practice. Refers to the most recent rules and regulations for manufacturing and quality control of pharmaceuticals and quasi-drugs as determined by the US Food and Drug Administration (FDA).
• **A research institution that conducts research on stem cells and regenerative medicine for the purpose of accelerating treatment for patients with unmet medical needs. Provides funds and cells to US and foreign institutions conducting research in California and stem cell research conducted by corporations.
• ***A research institution under the umbrella of the NIH (National Institute of Health), the medical research institute of the US Department of Health and Human Services that conducts research, training, and education for the prevention and treatment of heart, lung, blood, and sleep disorders.

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