It will also offer GMP manufacturing services in that Billingham location.
In terms of the driver behind the company’s decision to establish such services at its UK site, Andy Ross, spokesperson for Fujifilm Europe, told BioPharma-Reporter: “In the gene therapy viral vector CDMO market, Europe is the second largest after North America. Therefore, in order to expand the gene therapy drug CDMO business, Fujifilm will make an initial investment in the UK base this time and [later] expand the gene therapy drug CDMO business to Europe.”
The FDB viral vector process development laboratories in the UK are due to be online from spring 2021; the company outlined how the site will be outfitted with equipment to support upstream - suspension and adherent - processes, downstream processing and analytical development.
The GMP manufacturing capabilities of that CDMO are expected to be available at the UK base from autumn 2021; they will support bulk drug substance production of investigational drugs used in early-stage clinical trials.
The company previously announced it was constructing a research center at the UK site in March this year.
'A priority field'
Fujifilm has positioned its CDMO business for the gene therapy drug of viral vector process development and manufacturing as a priority field, said Ross. It is an area where the company has a strong track record, he added.
The company first established a viral vector and vaccine development and manufacturing offer in 2014 at its College Station, Texas site, in the US.
Flagging up Fujifilm’s USP in relation to viral vector and GMP manufacturing, Ross said the company is able to consistently provide flexible service from process development, formulation development, bulk drug substance production, fill finish and final packaging. “We have state of the art facilities and equipment, world class staff, and proprietary expression technologies to quickly develop and provide the optimum production process.”
Fujifilm, in another effort to grow this CDMO business, is making a capital investment in FDB’s Texas operations. Earlier this year, it announced that this site would be expanded with US$35m (€31m) earmarked for the upgrade.
Moreover, as part of the US government’s Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA), back in August, enlisted the support of FDB for the production of COVID-19 vaccine candidates.
The agreement will see Fujifilm Diosynth’s Texas site contracted to provide manufacturing capacity through the end of 2021.