Fujifilm Diosynth Biotechnologies has formally opened its new UK mammalian cell culture cGMP manufacturing facility at a ceremony performed by HRH the Duke of Gloucester.
The new facility has been built and commissioned in less than 15 months. It is the first facility of its kind in the UK, being purpose-built to utilise primarily single-use technologies for both upstream and downstream operations.
Designed with input from regulatory authorities and key customers, it will offer high flexibility for meeting customers’ needs. It has initially been commissioned with 200l and 1,000l bioreactors, with a 2,000l bioreactor already planned for 2014. The facility has been designed for rapid further expansion to meet customer demand. The company is already working on its first customer project for the facility.
This new capacity is the latest in a series of investments at both Fujifilm Diosynth Biotechnologies’ UK and Research Triangle Park, NC, US, facilities totalling £30m over the last two years. New cell line development and process development laboratories have been set up at both sites, and a 1,000l single-use bioreactor was installed at the RTP facility two years ago to supplement its 2,000l stainless steel train for the GMP production of mammalian cell culture biopharmaceuticals.
Steve Bagshaw, managing director of Fujifilm Diosynth Biotechnologies UK Limited, said: "I am delighted that we have been able to build and commission our new GMP mammalian cell culture manufacturing facility in such a short time frame.
"This new capacity, using the latest single-use technologies, provides our customers with a full lifecycle offering for mammalian cell culture biopharmaceuticals from our UK site, and complements our offering in microbial-based biologics. It reinforces Fujifilm’s commitment to lead the global Biologics CMO industry through continuous innovation and implementation of new technologies."