Fujifilm Diosynth Biotechnologies is one of the world’s leading cGMP Contract Development and Manufacturing Organisations for the biopharmaceutical industry, operating from two sites in Billingham, UK and Research Triangle Park, North Carolina, USA. We offer an extensive breadth of process development and cGMP manufacturing experience to meet our customers’ needs at every stage of the product lifecycle, from efficient protein expression, process design and GMP manufacture, through to process validation and commercial production for both mammalian and microbial biologics.
We employ over 900 employees across both sites, including more than 250 scientists and have over 20 years combined experience working with around 200 complex proteins. Both sites have received successful regulatory inspections from all key regulatory agencies, including FDA, MHRA, ANVISA, and Health Canada for the production of commercial products, demonstrating our strong track record in navigating the critical path through validation and regulatory approval.
Recently we have increased capacity for mammalian cell culture production at our RTP, NC site and also opened a CGMP mammalian cell culture facility using entirely single-use technology at our Billingham, UK site.
A ‘one-stop-shop’ is available for antibody drug conjugate (ADC) development through our alliance with Piramal Healthcare. The combined ADC development between Fujifilm and Piramal ensures rapid conjugation demonstration and route to market.