Fujifilm Diosynth Biotechnologies has formally opened its new mammalian cell culture cGMP manufacturing facility at a ceremony performed by HRH The Duke of Gloucester KG GCVO, a member of the UK Royal Family.
The new facility, which has been built and commissioned in under 15 months, 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 1000L bioreactors, with a 2000L 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, USA 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 1000L single-use bioreactor was installed at the RTP facility two years ago to supplement its 2000L 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 life-cycle 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.”
Fujifilm Diosynth Biotechnologies UK Limited is an industry leading biologics Contract Development and Manufacturing Organization. The company has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems.
Fujifilm Holdings Corporation, brings continuous innovation and leadingedge products to a broad spectrum of industries, including electronic imaging, digital printing equipment, medical systems, life sciences, graphic arts, flat panel display materials, and office products, based on a vast portfolio of digital, optical, fine chemical and thin film coating technologies.