Fujifilm : establishes "Cellular Dynamics International Japan" to launch iPSC business for drug discovery support in Japan.

September 29, 2015

FUJIFILM Corporation (President: Shigehiro Nakajima) has announced that it will establish Cellular Dynamics International Japan Co.,Ltd.(hereinafter 'CDJ'), a company for developing, manufacturing and marketing differentiated cells derived from induced pluripotent stem cell (iPS cell)*on October 1 for building iPSC business to support drug discovery in Japan. CDJ will initially import iPS cell-derived differentiated cells designed for drug discovery support, manufactured by the U.S.-based Fujifilm Group company, Cellular Dynamics International, Inc. (CEO Kazuyoshi Hirao, headquartered in Madison, Wisconsin; hereinafter 'CDI'), and market them to universities, research institutes and private enterprises in Japan.

Currently, animal testing is conducted in the development of innovative drugs to confirm candidate drugs' efficacy and safety, and this is followed by clinical trials conducted on human subjects. However, since the development of many of such drugs that have passed animal testing becomes halted in the stage of human clinical trials, there is a growing market need for a way of confirming efficacy and safety on human cells before clinical trials can be initiated. Amidst this market sentiment, there has been a global trend towards applying iPS cells, which has the capacity for infinite reproduction and differentiation, to the field of drug discovery. In Japan, various pharmaceutical companies have partnered with numerous government research institutes to examine the use of iPS cell-derived differentiated cells on safety assessment for pharmaceutical development. In particular, efforts are being made to standardize safety assessment, using iPS cell-derived cardiomyocytes.
In May this year, Fujifilm acquired CDI, a global leader in the development and manufacturing of iPS cells. CDI leads the iPS cell business, already supplying numerous users including large pharmaceutical companies with high-quality iPS cell-derived differentiated cells in 12 types for drug discovery assistance including cardiomyocytes, neurons and hepatocytes as well as custom-made iPS cell-derived differentiated cells.

Fujifilm is setting up CDJ in Japan so as to supply CDI's iPS cell-derived differentiated cells and custom-made iPS cell-derived differentiated cells. CDJ also plans to set up a manufacturing and R&D base in Tonomachi (Kanagawa, Japan), which is designated as a National Strategic Special Zone**and an International Strategic Zone***. The site will be used to identify user needs on the quality and other properties of iPS cell-derived differentiated cells, and actively take on joint research with universities, research institutes and private enterprises to develop iPS cell-derived differentiated cells that can contribute broadly to the field of drug discovery support including chemical compound exploration, disease research and pharmacological evaluation. In the future, advanced production technologies, nurtured through Fujifilm's photographic film development, will be applied for mass production and stable distribution of high-quality iPS cell-derived differentiated cells in Japan.

Fujifilm has developed recombinant peptide (RCP)*4, which has excellent biocompatibility and can be processed into various shapes, as a 'scaffold*5' material suitable for creating 3D cell structures. In the future, RCP can be used to build 3D-structured cells to enable more advanced pharmaceutical assessment in drug discovery assistance. Also in the field of regenerative medicine, where iPS cell application is anticipated, Fujifilm's high-functional material technologies and engineering technologies can be combined with CDI's iPS cell-related technologies / know-how and Fujifilm Group company Japan Tissue Engineering's cell production technologies for cell therapy for a synergistic effect, contributing to the establishment of the regenerative medicine industry.

• *iPS cells (induced pluripotent stem cells) that are directed to differentiate for specialized application as cardiomyocytes, neurons and hepatocytes.
• **National Strategic Special Zone is designated by the national government based on the perspectives of strengthening the interntonal competitiveness of industry and promoting the creation of bases of international economic activities by putting high priority to advancing structural reform of the socioeconomic system . In the Natonal Strategic Special Zone, deregulations are being promoted comprehensively and intensively.
• ***International Strategic Zones are a type of Comprehensive Special Zones, designated with the aim of improving Japan's economic and social vitality and achieving sustainable development by strengthening international industrial competitiveness and promoting regional revitalization measures comprehensively and intensively in response to various changes in industrial structures, international competition conditions as well as other socioeconomic factors such as rapid population aging.
• *4Synthetic proteins modelled on human Type 1 collagen manufactured with yeast cells using genetic engineering techniques.
• *5Cells attach to an extracellular material (also called extracellular matrix or scaffold), which provides a structure necessary for normal growth.

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FUJIFILM Corporation
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