Fujifilm Expands Biopharmaceutical Contract Development and Manufacturing Business, Increasing Monoclonal Antibody Capacity for Process Development and GMP Production at U.S.A. and U.K. Sites
Company accelerates investment of approximately 3.2 billion yen for boosting CDMO capacity
TOKYO--(BUSINESS WIRE)--FUJIFILM (President: Kenji Sukeno) is to invest a total of 3.2 billion yen on its CDMO*1 sites in the U.S.A. and the U.K. in order to accelerate the expansion of the company's business for developing and manufacturing biopharmaceuticals*2 under contract for other parties.
In addition to investing approximately 2.2 billion yen in a GMP facility dedicated to the production of monoclonal antibodies at the FUJIFILM Diosynth Biotechnologies (FDB) site in College Station, Texas, U.S.A., the company is also investing approximately 1.0 billion yen at its Wilton Centre site in Redcar, U.K., to expand the floor area of the development site of production processes for antibodies and install an additional facility. The new investment will expand the existing Saturn mAb™*3 Process Development Laboratories dedicated to the development of monoclonal antibodies under FDB’s Platform. From Fall 2018 onwards, the new facilities will ramp up operation, bolstering the company's ability to accept orders from its customers for process development and manufacturing in the field of antibodies.
In March 2017, Fujifilm established the company’s Bio CDMO Division which oversees the expansion of its contract development and manufacturing business focused on FDB. Currently, FDB is concentrating on providing solutions to deliver biotherapeutics and advanced therapies to its customers. In the area of monoclonal antibody, the Saturn mAb platformTM offering is capable of providing a single integrated and efficient workflow that starts with the development of production processes and also includes the provision of drugs for clinical trials as well as the commercial production of biopharmaceuticals. The company is working to strengthen its business capacity through measures including the installation of three single-use*4 2,000-litre mammalian cell culture tanks, scheduled to begin operation early 2018 in the cGMP-compliant*5 production facility that has recently been completed at Texas site as well as the company’s new U.K facility that opened in September.
In order to respond to growing customer needs in this field, Fujifilm has decided to make additional investments earlier than scheduled. Three new single-use 2,000-litre mammalian cell culture tanks are to be installed at the Texas facility for a total of six tanks. In addition, the company will be expanding the floor area of process development site in the U.K. to nearly double the existing space of approximately 930 m2 while also expanding the range of state-of-the-art equipment with the latest high-throughput technologies, including fully automated bioreactors and chromatography systems, to enable for rapid and efficient monoclonal antibody manufacturing process readiness. These measures will bolster the company's contract development and manufacturing business by using the Saturn mAb platformTM for the process development and manufacturing of antibodies. Total cumulative investment in the platform will reach approximately 17.2 billion yen.
At the Texas site, the new production block has sufficient space for expansion up to a maximum of 12 cell culture tanks, which will allow the company to respond promptly to customer demands for increased production and future demand growth.
Fujifilm will continue to further expand its biopharmaceutical production capabilities, 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 100 billion yen in its CDMO business by fiscal year ending March 2024.
Biopharmaceuticals are gaining an increasing share of the overall pharmaceuticals market due to the potential to achieve strong results with very few side-effects. Biopharmaceutical production requires the use of advanced manufacturing technologies and facilities for culturing, separation and purification. The number of pharmaceutical companies and bio-venture companies outsourcing process development and manufacturing activities to CDMOs with excellent technologies and facilities is increasing. The contract development and manufacturing market for biopharmaceutical is projected to achieve growth of 8%*6 per annum accordingly.
Fujifilm is determined to make further progress through the growth strategies of its business for biopharmaceutical contract development and manufacturing. In addition to accelerating expansion of the business, Fujifilm will also contribute to the further development of the pharmaceuticals industry through the stable provision of high-quality pharmaceuticals.
| *1 | CDMO is an abbreviation of Contract Development & Manufacturing Organization, and it refers to a company or organization that accepts contracts from third parties for the development of drug production processes and for drug manufacture. CDMOs provide pharmaceutical companies with a wide range of services including the development of cell strains in the initial stages of drug development, as well as process development, stability testing, the development and manufacture of drugs for clinical trials, and the manufacture of the final commercial product. | |
| *2 | Biopharmaceuticals are pharmaceuticals that harness biological molecules such as proteins to achieve mechanisms that cannot be achieved by low-molecular-weight drugs. The category includes not only vaccines but also insulin, growth hormones, and antibody medicines. Antibodies are compounds that play a major role in the immune system, protecting the body by detecting pathogens, cancer cells and other abnormal cells within the body. Antibody medicines, which antibodies are the principal active component, have an effect by combining with a specific target, known as an antigen. | |
| *3 | This platform provides highly efficient production workflow of monoclonal antibodies through FDB's proprietary technology base. It realizes the production of high-quality antibodies efficiently by designing the workflow on the whole from the process development such as cultivation conditions, the application of the process to the investigational drug / medicine production, as well as up to the commercial production,. | |
| *4 | These specifications use plastic bags on the inside of the culture tank. The replacement of the bag not only removes the need for cleaning and disinfecting processes, it also reduces the risk of foreign body contamination. | |
| *5 | An abbreviation of Current Good Manufacturing Practice, which refers to the most recent production management and quality control management regulations for pharmaceuticals and other medicated products as defined by the US Food And Drug Administration (FDA). | |
| *6 | According to Fujifilm data. | |
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[Summary of investment in Saturn mAb platform] |
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| Texas, US site | UK site | |||||||
| Company name | FUJIFILM Diosynth Biotechnologies Texas, LLC | FUJIFILM Diosynth Biotechnologies UK Limited | ||||||
| Location | College Station, TX, US | Wilton Centre, Redcar, UK | ||||||
| Aim |
Stronger production capacity for |
Development of production processes |
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| Details |
Production block |
The latest advanced devices for the |
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| Start of operations |
Early 2018 2,000 liters ×3 tanks |
Opened in September 2017 930m2 |
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* 7 The investment announced this time |
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[Summary of FUJIFILM Diosynth Biotechnologies] |
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| Company name |
FUJIFILM Diosynth |
FUJIFILM Diosynth |
FUJIFILM Diosynth |
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| Location | Billingham UK | Morrisville, NC, US | College Station, TX, US | |||||||||
| CEO | Steve Bagshaw | Steve Bagshaw | Steve Bagshaw | |||||||||
| Shareholders |
Fujifilm (80%) |
Fujifilm (80%) |
FUJIFILM Diosynth |
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About Fujifilm
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 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.