The CMO’s ability to engage early and often with the MHRA on the design and philosophy behind the facility helped Fujifilm to create what the regulator is now calling “the first purpose-built and now licensed facility in Europe to utilise single-use technology and hardware throughout the manufacturing operations, from cell line right through to Bulk Drug Substance filling.”
Begun in 2011, the UK site employs both a TAP bioreactor for microbial fermentations, and a single-use 2,000L bioreactor.
Subhash Chaudhary, Director Strategic Investments, Fujifilm Diosynth Biotechnologies said: “In expanding our Billingham site, we needed to access advice, guidance and knowledge from experts at MHRA who helped us really think through the design of the new facility, including future-proofing it against potential changes in regulations that could have cost us significant time, and therefore lost revenue, to rectify.”
The site annually supports around 50 different clients, covering a range of products and processes including the production of monoclonal antibodies, vaccines and antibody drug conjugates that help to fight cancers, auto-immune, heart and inflammatory conditions.
Future-proofing the site has saved Fujifilm from “a prolonged shut down to implement any changes resulting from amended regulations at a later date,” the UK regulator says. “This also provides the facility with significant differentiation from competitors.”
The MHRA also clarified that the benefits of the single-use approach include: “eliminating complex cleaning cycles; reducing the likelihood of cross-contamination; speeding up product change-overs, and; improving operational safety of the site, as steam and caustic substances are no longer required in the production cycle.”
By developing its own cell-line and process development platform technologies, Fujifilm has reduced significantly the cell line development, scale-up and clinical manufacturing times of biologics to critical phase 1 clinical stage.