Fujifilm Diosynth Biotechnologies is one of the world's leading providers of contract process development and manufacturing services for the biopharmaceutical industry. Formed in April 2011, the company has over 800 employees operating from two sites in Billingham, UK (formerly Avecia Biologics) and Research Triangle Park, North Carolina, USA (formerly Diosynth Biotechnology).
Together we have over 15 years of experience working with over 150 complex proteins, and both sites have been successfully FDA inspected for the manufacture of commercial products, demonstrating our strong track record in navigating the critical path through validation and regulatory approval.
Over the last twelve months we have announced additional mammalian cell culture capacity at both our RTP site (commissioned early 2012) and a new cGMP mammalian cell culture facility at our Billingham, UK site (scheduled to be on stream Q3 2013).
As a full-service contract manufacturer, we offer an extensive breadth of process development capabilities to meet our customers' needs at every stage of the product lifecycle.
Our experience ensures process development is applied appropriately, dependent upon the development needs of customer products at different clinical stages.
At our sites in Billingham, UK, and Research Triangle Park, NC, US, we offer a broad range of mammalian and microbial cGMP manufacturing capabilities. We employ protocol-driven technology transfer processes to bring in projects from customers and seamlessly integrate them into these facilities. Our facilities have received successful regulatory inspections from all key regulatory agencies.
Microbial:
Mammalian:
The following additional services are offered to reduce complexity and risk of multiple suppliers:
Fujifilm Diosynth Biotechnologies
Belasis Avenue
Billingham
TS23 1LH
United Kingdom
Tel: +44 1642 363511
Email:
enquiries@fujifilmdb.com
URL:
www.fujifilmdiosynth.com
Fujifilm Diosynth Biotechnologies is a full-service contract manufacturing partner, starting with cGMP cell banking facilities for the production of master and working cell banks.
Fermentation scales range up to 5,000l for microbial production for Phase III clinical supply, process validation and commercial supply, with refold volumes up to 10,000l.