The company is increasing monoclonal antibody capacity for process development and GMP production at its US and UK sites
2000 litre mammalian cell culture tank
Fujifilm Corporation is to invest a total of YEN3.2 bn (£21.5 m) on its CDMO sites in the US and the UK to accelerate the expansion of the company's business for developing and manufacturing biopharmaceuticals under contract for other parties.
In addition to investing approximately YEN2.2 bn in a GMP facility dedicated to the production of monoclonal antibodies (mAbs) at the Fujifilm Diosynth Biotechnologies (FDB) site in College Station, Texas, US, the company is also investing approximately YEN1 bn at its Wilton Centre site in Redcar, UK, 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 mAbs under FDB's Platform. From Atumn 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 mAbs, 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 2000 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 UK facility that opened in September.
Fully automated bioreactors in production process development site in Redcar, UK
These single-use tanks 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.
To respond to growing customer needs in this field, Fujifilm has decided to make additional investments earlier than scheduled. Three new single-use 2000 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 UK to nearly double the existing space of approximately 930 m2 while also expanding the range of 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.