2,000-litre mammalian cell culture tank
Fujifilm is to invest a total of 3.2 billion yen on its CDMO 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 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., 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 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 platform 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 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 platform 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.