Biologics production facility expansion
Fujifilm Diosynth Biotechnologies (FDB), a subsidiary of Japanese multinational conglomerate Fujifilm, is expanding its large-scale biologics production facility in Hillerod, Denmark.
In June 2020, Fujifilm announced a capital investment of around JPY100bn ($928m) in the Hillerod site to double its existing drug substance manufacturing capacity and add fill/finish capabilities. The investment will also improve the facility’s existing assembly, labelling and packaging services.
In March 2021, a virtual ground-breaking ceremony to commence the large-scale cell culture expansion project was held. The project’s construction is due to be completed in 2023 and is expected to generate 300 new employment opportunities in Denmark by the end of 2023.
The expansion will make the Denmark facility one of the major large-scale manufacturing plants in the industry. Six 20,000l bioreactors will be added to the facility, doubling its current bulk drug substance production capacity to 12. A fully automated, cutting-edge fill/finish capability that can produce up to around 35 million units a year will also be added for large-scale biologics production, along with a new packaging line that will be used to assemble different types of auto-injectors and automatic labelling.
The new packaging line is anticipated to be operational in 2022, while the fill/finish production line will start operations by mid-2023. The large-scale cell bulk drug substance expansion, which marks the last phase of the project, is expected to commence operations by the end of 2023.
In August 2019, Fujifilm acquired a biologics manufacturing site owned by US-based Biogen in Hillerod, Denmark, for around $890m. The facility became FDB’s fourth biopharmaceutical manufacturing site in the world. At the time of acquisition, the site had a capacity of 90,000l, comprising six 15,000l bioreactors.
In October 2020, FDB agreed to manufacture Eli Lilly and Company’s Covid-19 therapeutic antibody at its Hillerod site. The company reserved manufacturing space for the Covid-19 Therapeutics Accelerator, which was partly funded by the Bill and Melinda Gates Foundation, under an agreement with Eli Lilly and Company for the prevention and treatment of Covid-19.
A partnership between Fujifilm and Mitsubishi, FDB is a contract development and manufacturing organisation (CDMO) for biologics, viral vaccines and viral vectors.
The company operates sites in the US (Texas and North Carolina), UK (Billingham, Redcar and Teesside) and Denmark (Hillerod).
FDB specialises in developing and manufacturing recombinant proteins, monoclonal antibodies, viral products, vaccines, medical countermeasures and other large molecules.
Some of the core services offered by the company include process development, analytical development and current good manufacturing practice (cGMP) manufacturing.
FDB’s premium services include process development, cell-line development, analytical development and clinical and FDA-approved commercial manufacturing.
The Hillerod site’s expansion is a part of FDB’s global expansion efforts. In January 2019, the company added 7,000ft² of laboratory space at Wilton laboratories in Teesside, UK, to enhance its cell culture process development capacity. FDB is also investing $55m in a new Gene Therapy Innovation Centre near its facility in College Station, Texas. The facility will be equipped with upstream, downstream and analytical development technologies to meet the increasing demand in the viral gene therapy market.
In January 2021, Fujifilm announced an investment of more than $2bn to establish a new large-scale cell culture production site in the US. The investment will allow the company to accelerate the growth of its biopharmaceutical contract development and manufacturing business.
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