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FUJIFILM Corporation (President: Kenji Sukeno) will increase production capacity by investing about JPY14 billion ($130m) in the USA and UK in order to expand the business of its BioCDMO Division.
In the USA, at FUJIFILM Diosynth Biotechnologies Texas, LLC (FDBT), a JPY10 billion ($93m) cGMP production facility has been completed. This facility was built in part with funding from BARDA (Biomedical Advanced Research and Development Authority), an office of the U.S. Department of Health and Human Services, and Fujifilm plans to invest an additional JPY3 billion ($28m) to outfit the facility with mammalian cell culture bioreactors. This facility will start operation at the beginning of 2018. FUJIFILM Diosynth Biotechnologies Texas, LLC (FDBT) was acquired by Fujifilm through FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) in 2014. In March of this year, FDBT became a wholly owned subsidiary of FDBU exercising the option early included in the initial deal to take 100% ownership. In addition, a JPY1 billion ($9m) investment will be made to expand the Process Development capabilities at FUJIFILM Diosynth Biotechnologies UK Limited near to its Billingham, UK site. This facility is scheduled to be operational in summer of 2017.
The FDBT facility will be the manufacturing center of excellence for the company's Saturn Monoclonal Antibody Platform with an initial cell culture capacity of 6,000L (3X 2000L bioreactors). The design of the facility allows for future expansion that can accommodate up to 24,000L of upstream capacity to meet much needed customers' clinical and commercial demands. In the United Kingdom, the investments include the establishment of a dedicated Mammalian Cell Culture Center of Excellence. These laboratories span over 10,000 sq. ft. and are designed to incorporate the latest high-throughput technologies, including fully automated bioreactors and chromatography systems, to enable for rapid and efficient monoclonal antibody manufacturing process readiness. These assets will enable Fujifilm to provide 'best in class' facilities, technology and operational know how to the industry. They are also a key in our continuing commitment to develop future Medical Counter Measures and Pandemic Flu response candidates for our long term Partners the CIADM (Center for Innovation in Advanced Development and Manufacturing), BARDA and other third party customers.
“FUJIFILM Diosynth Biotechnologies is committed to its vision of being Leaders in the Bio CDMO space,” said Steve Bagshaw, Chief Executive Officer, FUJIFILM Diosynth Biotechnologies, “Our commitment is to transform the CDMO business through innovation and with our great people — providing long term support to our partners fulfilling our core purpose as ‘Partners for Life - Advancing tomorrow's medicines’.”
Biopharmaceutical production requires the use of advanced manufacturing technologies and facilities for culturing, separation and purification. The number of companies outsourcing process development and manufacturing activities of biopharmaceuticals to CDMOs is increasing. The contract development and manufacturing market is projected to achieve growth of 8% per annum* accordingly.
Fujifilm will continue to grow and expand its existing capabilities in addition to engaging in external collaborations to increase capacity, and it will further develop high efficiency and high productivity technology by combining group technologies, to continue to grow further the business. It is targeting sales of JPY100 billion in its BioCDMO business by 2023.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham, UK, RTP, North Carolina and College Station, Texas. FUJIFILM Diosynth has over twenty five years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com.
FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
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