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Fujifilm Diosynth Biotechnologies' UK Site Receives Renewed Medicines and Healthcare Products Regulatory Agency Manufacturing Licence


10/9/2013 9:24:18 AM

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Billingham, UK/Morrisville, NC, USA, October 9, 2013 / B3C newswire / - Fujifilm Diosynth Biotechnologies has announced that it has received a renewal of its Manufacturer’s Licence from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The Licence authorises commercial manufacturing at the company’s Billingham, UK site, and was received with zero critical or major observations.

The Inspection included the company’s new cGMP mammalian cell culture manufacturing facility, which is on schedule for imminent commissioning. This facility, which will primarily utilise single-use technologies, has been designed with input from regulatory authorities, in particular the MHRA, and key customers to offer high flexibility for meeting customers’ needs. It will initially offer 200L and 1000L single-use bioreactors, with 2000L bioreactors already planned for 2014. The company announced that the cGMP Cell Banking Facility, which forms part of the larger plant, was fully commissioned in April 2013, and has already processed its first cell banks.

The Licence also covers commercial manufacturing of microbial-based biologics in the company’s large scale manufacturing assets. The company currently has FDA-approval for manufacture of two commercial products in these facilities.

Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies’ UK site said “We are delighted to have received a renewal of our Manufacturer’s Licence from the MHRA. Our customers can be assured that this demonstrates our commitment to quality and ultimately patient care, and confirms our position as a top player in the CMO field for both microbial and mammalian biopharmaceuticals.”

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 microbial and mammalian 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 biologic 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 10 companies around the world granted U.S. patents in 2011, and in the year ended March 31, 2013, had global revenues of $23.6 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship.

* At an exchange rate of 94 yen to the dollar.

Contact:

Bridget Hall, Communications Manager

Fujifilm Diosynth Biotechnologies

Tel : +44 (0)1642 367320

Cell: +44 (0)7796 938929

Email : bridget.hall@fujifilmdb.com

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