Fujifilm Diosynth Biotechnologies Significantly Expands Mammalian Cell Culture cGMP Capabilities
Published: Jun 19, 2012
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.
About Fujifilm Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies UK Limited is an industry leading biologics Contract Development and Manufacturing Organization. Fujifilm Diosynth Biotechnologies 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. The company offers a comprehensive list of services from cell line development, including its proprietary pAVEway™ system to process development, analytical development, clinical and commercial manufacturing. Fujifilm Diosynth Biotechnologies is also located in Research Triangle Park, NC, USA as FUJIFILM Diosynth Biotechnologies U.S.A., Inc. Both sites have been FDA-approved for the production of commercial products
About FUJIFILM Holdings Corporation
FUJIFILM Holdings Corporation, Tokyo, Japan, brings continuous innovation and leading-edge 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. The company was among the top 17 companies around the world granted U.S. patents in 2011, and in the year ended March 31, 2012, had global revenues of $27.8 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit www.fujifilmholdings.com