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cGMP Manufacturing at 1000L scale


18th June 2012

FUJIFILM Diosynth Biotechnologies significantly expands Mammalian Cell Culture cGMP capabilities... more >>

FUJIFILM Diosynth Biotechnologies significantly expands Mammalian Cell Culture cGMP capabilities

Billingham, UK/Morrisville, NC, USA: 18th June 2012 - FUJIFILM Diosynth Biotechnologies has announced it is further increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell line development/process development, and the addition of a new multi-product cGMP facility at its Billingham, UK site.

The first phase has seen development of the company's cell line and process/analytical development facilities, including addition of the latest high throughput technologies to enable rapid transition of biologics from discovery to clinic. This is supported by a significant increase of the Mammalian Development Group to create a dedicated expert pool of scientists for both new technology development and delivery of customer programmes.

Work has also commenced on a state-of-the-art cGMP Cell Bank and 1000L biologics manufacturing facility on the Billingham site. This facility will be based upon single-use technology for both upstream and downstream operations, offering flexible, integrated solutions and speed to clinic.

Steve Bagshaw, Managing Director, FUJIFILM Diosynth Biotechnologies UK business, said "This expansion will build upon our leadership position in microbial-based biopharmaceuticals, reinforcing FUJIFILM's commitment to lead the global Biologics CMO industry through continuous innovation and implementation of new technologies. This European facility, together with our new cell line development and expanded process development capability, complements our USA operation and will provide our customers with a full life-cycle offering, from gene to GMP, for pre-clinical studies, early phase to mid-phase clinical production and beyond".

This latest development is the next step of the company's strategy to grow CMO services in Europe and the USA based on both microbial and mammalian cell culture. The company announced the addition of a 1,000L single-use bioreactor at its Research Triangle Park, NC, USA facility in May 2011, supplementing its existing 2,000L stainless steel train at the cGMP manufacturing plant.

The new Cell Bank manufacturing facility in Billingham will be available from Q2, 2013 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.

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