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Fujifilm Diosynth Biotechnologies’ Biologics Production Facility Expansion

Japanese multinational conglomerate Fujifilm has made a capital investment of JPY100bn ($928m) for the expansion of its subsidiary Fujifilm Diosynth Biotechnologies’ (FDB) biologics production facility in Hillerod, Denmark. This investment envisions a doubling of the facility’s existing drug substance manufacturing capacity and add/fill capabilities, as well as an improvement of its existing assembly, labelling and packaging services.

March 2021 saw a virtual ground-breaking ceremony inaugurating the extensive cell culture expansion project, expected to be completed in 2023 and to generate 300 new employment opportunities in Denmark by the end of that year.

Expansion details
With six 20,000l bioreactors being added to double its current bulk drug substance production capacity to 12, a fully automated, cutting-edge fill/finish capability of 35 million units a year, and a new packaging line for assembling different types of auto-injectors and automatic labelling, the Denmark site will be one of the prime large-scale manufacturing facilities in the industry.

The packaging line is anticipated to be operational in 2022, the fill/finish production line by mid-2023, and the large-scale cell bulk drug substance expansion by the end of 2023.

Facility background
The previously US-owned (Biogen) site was acquired by Fujifilm in August 2019 for about $890m, becoming FDB’s fourth biopharmaceutical manufacturing site in the world, with a capacity of 90,000l at the time.

Covid-19 therapy manufacturing capability
In light of its agreement with Eli Lilly and Company to manufacture its Covid-19 therapeutic antibody at its Hillerod site, FDB reserved space for the Covid-19 Therapeutics Accelerator, which was partly funded by the Bill and Melinda Gates Foundation as part of an agreement with Eli Lilly and Company for the prevention and treatment of Covid-19.

Marketing commentary on Fujifilm
FDB is a contract development and manufacturing organisation (CDMO) created in partnership between Fujifilm and Mitsubishi for biologics, viral vaccines, and viral vectors, and has sites in the US, UK, and Denmark. FDB specialises in developing and manufacturing recombinant proteins, monoclonal antibodies, viral products, vaccines, medical countermeasures, and other large molecules. Its core services include process development, analytical development, and current good manufacturing practice (cGMP) manufacturing; the former two, together with cell-line development and clinical and FDA-approved commercial manufacturing, count in FDB’s premium services.

FDB’s investment in its Hillerod facility is one of many made towards global expansion. 7,000ft 2 of laboratory space was added to Wilton laboratories in Teesside, UK, in January 2019, and $55m are being invested in a new Gene Therapy Innovation Centre near its College Station facility in Texas in order to meet increasing demand in the viral gene therapy
market. Fujifilm also announced an investment of over $2bn this January in a new cell culture production site in the US, making way for the company to hasten the expansion of its biopharmaceutical contract development and manufacturing business.

(Source: Pharmaceutical Technology, 2021)