FUJIFILM Cellular Dynamics to Establish New Facility for Production of Human iPS Cell Therapy Applications
Fujifilm is investing in the cGMP-compliant facility located in Madison, Wisconsin with the goal to begin operations by March 2020
MADISON, Wis., January 3, 2019 -- 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.
FUJIFILM Cellular Dynamics, Inc. (FCDI), is a leading developer and supplier of human cells used in discovery, toxicity testing and regenerative medicine applications. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, FCDI is committed to advancing life science research and transforming the therapeutic development process in order to fundamentally improve human health. The company’s inventoried iCell® products and donor-specific MyCell® Products are available in the quantity, quality, purity and reproducibility required for drug and cell therapy development. For more information, please visit: www.FujifilmCDI.com
FUJIFILM Holdings Corporation, Tokyo, Japan brings cutting-edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products.These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2018, the company had global revenues of $23.0 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
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*1 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).
*2 In January 2017 Cynata executed a license option agreement with FUJIFILM Corporation of Japan for the development and commercialization of certain Cynata technology, including Cynata’s lead induced pluripotent stem cell(iPSC)-derived therapeutic mesenchymal stem cell (MSC) product, CYP-001, forgraft-versus-host disease (GvHD). As part of the transaction, Fujifilm acquired an equity position in Cynata through the purchase of 8,088,403 ordinary shares in Cynata, leading to Fujifilm becoming the largest shareholder in the Company with an approximate 9% stake.