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Fujifilm Diosynth Biotechnologies Expands Cell Culture Manufacturing Capacity With Addition Of Two New 2,000L Single-Use Bioreactors



8/19/2014 9:14:41 AM

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Billingham, Teesside, UK and Research Triangle Park , NC, USA, 19th August 2014 : FUJIFILM Diosynth Biotechnologies has announced continued expansion of its cell culture manufacturing capabilities with the add ition of two 2000L single-use bioreactors. One each of these is being installed at t he company’s sites in Research Triangle Park (RTP), NC, USA and Billingham, UK.

The new reactors will complement the range of vessels a t both sites, adding further flexibility for customer requirements. Each site currently operates 1000L single-use bioreactors with 250L to 1,000L operating volumes, wit h an additional 200L single- use bioreactor in the UK, and a 2000L stainless steel t rain in RTP, which has been in place for a number of years manufacturing a range of p roducts.

“The addition of these two new bioreactors will meet t he demand we are seeing for a 2000L platform, and offer a cost-effective, low-risk rou te to market through ‘scaling- out’ from early phase to commercial manufacture” says Mr. Steve Bagshaw, Chief Executive Officer, FUJIFILM Diosynth Biotechnologies. He a dds “Being similar to our existing bioreactors means they will fit seamlessly into o ur facilities. Having identical single-use operations on both sides of the Atlantic offe rs our customers flexibility and easy access to global markets. Combined with the expertis e of our process development scientists to produce high-titer cell lines , our focus on single-use bioreactor technology for cell culture processes is world class.”

The company has over 15 years’ cell culture manufacturing experience with significant single-use facility expansions in the last thr ee years at both sites. The facilities have been inspected by key regulatory authorit ies and utilise both traditional platforms as well as the latest single-use technologies. The new 2000L bioreactors are expected to be operational by November 2014 in the US and in the UK in January 2015.

Mr. Bagshaw concluded “With these expansions, FUJIFILM Dio synth Biotechnologies is able to deliver a significantly en hanced, full life cycle ‘Gene to GMP’ service for our customers".

About Fujifilm Diosynth Biotechnologies (http://www .fujifilmdiosynth.com) FUJIFILM Diosynth Biotechnologies UK Limited is an ind ustry leading biologics Contract Development and Manufacturing Organization. FUJIFILM Diosynth Biotechnologies has extensive experience in the development and manufactu ring of recombinant proteins, vaccines, monoclonal antibodies, among other large mo lecules expressed in a wide array of microbial, mammalian, and insect systems. The company o ffers a comprehensive list of services from microbial and mammalian cell line develo pment, including its proprietary pAVEway™ system, to process development, analytical devel opment, clinical and commercial manufacturing. FUJIFILM Diosynth Biotechnol ogies is also located in Research Triangle Park, NC, USA as FUJIFILM Diosynth Biotechnol ogies U.S.A., Inc. Both sites have been FDA-approved for the production of commercial bi ologic products.

About FUJIFILM Holdings Corporation (http://www.fuj ifilmholdings.com)

FUJIFILM Holdings Corporation, Tokyo, Japan brings cont inuous innovation and leading- edge products to a broad spectrum of industries, incl uding: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly fun ctional materials, such as flat panel display materials; optical devices, such as broad cast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and productio n technologies. In the year ended March 31, 2014, the company had global revenues of $23 .7 billion, at an exchange rate of 103 yen to the dollar. Fujifilm is committed to envir onmental stewardship and good corporate citizenship. For more information, please visit: www. fujifilmholdings.com.

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