Fujifilm Announces the on-time Completion of Qualification Activities and cGMP Readiness of its SaturnTM High Throughput mAb Manufacturing Facilities in College Station, Texas
The Company also revealed expansion of its Apollo™ Cell Line Development capabilities at its Billingham, U.K. Site
January 17, 2018
College Station, TX, U.S.A., ‒ FUJIFILM Corporation (President: Kenji Sukeno) today announced the on-time completion of Qualification activities, enabling commencement of cGMP operations for its Saturn™ mAb manufacturing facilities at FUJIFILM Diosynth Biotechnologies (“FDB”), a world leading cGMP Contract Development and Manufacturing Organization in College Station, Texas. In addition, FDB also announced the expansion of its Apollo™ cell line development capacity at its Billingham, U.K. site.
In recognition of this significant milestone, Kenji Sukeno, President of FUJIFILM Corporation visited the College Station, Texas facility to congratulate staff and participate in a celebration attended by FDB leadership, Texas A&M University representatives, BARDA representatives, and local government officials including Bryan Daniel, Executive Director of the Governor’s Office of Economic Development & Tourism.
“Developers of cell culture-based therapies need reliable and proven partners with the development and manufacturing experience to support the delivery of therapies to patients,” said Kenji Sukeno, President of FUJIFILM Corporation. “Through continuous technology innovation and commitment to excellence, Fujifilm’s focus on the bio CDMO business has ensured the company’s leadership and growth by using Fujifilm’s approach to manufacture under constant conditions and superior quality control, developed for the photographic film business.”
The Saturn mAb Platform™ services are the result of years of experience developing and optimizing monoclonal antibodies processes with efficient cGMP production and batch disposition. Designed to enable rapid manufacturing capacity, Saturn mAb Platform™ is capable of providing a single integrated and efficient workflow. The new cGMP manufacturing building, which is the primary manufacturing facility for Saturn™ mAb Services has been designed to accommodate 12 x 2000L SUB bioreactors, with the ability to expand further. Combining with the facility, Fujifilm’s manufacturing technologies and FDB’s Apollo™ Mammalian Expression Platform, FDB is capable of high efficient production to meet client specific demands or the growing demands of the industry.
FDB also announced the expansion of its Apollo™ cell line development capacity at the Billingham, UK site. “Additional capacity is required to support the growing portfolio of clients that are seeking services from Gene to GMP as part of our Saturn™ offering” said Steve Bagshaw, CEO of FUJIFILM Diosynth Biotechnologies.
Under the bio CDMO division, established March 2017, Fujifilm will further develop high efficiency and high productivity technology by combining group technologies to advance the business. The company has set a target sales goal for its CDMO business of 100 billion yen by fiscal year ending March 2024.Fujifilm will also contribute to the further development of the pharmaceuticals industry through the stable provision of high-quality pharmaceuticals.
FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham and Redcar, 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 Corporation, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings. The company brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic and thin film coating technologies. In the year ended March 31, 2017, the company had global revenues of $20.7 billion, at an exchange rate of 112 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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