FUJIFILM ANNOUNCES THE OPENING OF ITS FLEXIBLE MANUFACTURING FACILITY FOR THE PRODUCTION OF CLINICAL AND COMMERCIAL GENE THERAPIES
January 24, 2018
College Station, TX, U.S.A., ‒ FUJIFILM Diosynth Biotechnologies (Fujifilm), a leading Contract Development and Manufacturing Organization (CDMO) with experience focused on the development and manufacture of recombinant biopharmaceuticals and Advanced Therapies, has announced the opening of its state-of-the art Flexible Manufacturing Facility (FBF) in College Station, Texas.
The 80,000 square feet facility utilizes state-of-the-art Mobile Clean Room technology to allow for multiproduct and multi-class production of Advanced Therapies.
“With flexibility at the core of its design, the FBF can produce both clinical and commercial therapeutics; it is ready to make batches today and is capable of rapid expansion to meet the growing demands of the industry,” said Martin Meeson, President and COO of FUJIFILM Diosynth Biotechnologies, USA.
The FBF complements the existing Process and Analytical development and manufacturing capabilities at National Centre for Therapeutic Manufacturing operated by Fujifilm which is equipped for Phase I/II GMP production of Advanced Therapies and is also located in College Station, Texas.
“Developers of gene therapies need reliable and proven partners with the ability to support not only clinical production but to be ready to move swiftly into commercial production,” said Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, Texas site. “For many of the gene therapies in development, Breakthrough Status designation is desired to bring the therapies quickly to patients therefore selecting the right manufacturing partner will be key.”
The gene therapy market has been steadily growing over the past decade and it is expected to continue to grow at a significant pace. Clinical studies have demonstrated the efficacy of gene therapies for many indications. In 2017 alone, three gene therapy treatments were approved in the United States by the FDA and many other candidates are in clinical trials.
FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Billingham and Redcar, UK, RTP, North Carolina and College Station, Texas. FUJIFILM Diosynth has over twenty five years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com
FUJIFILM Holdings Corporation, Tokyo, Japan delivers innovative solutions across a broad range of businesses, derived from the depth of knowledge of core and fundamental technologies required for the complex design, engineering and manufacturing of photographic film. These business fields include medical digital radiography, women's health, endoscopy, ultrasound, medical informatics, CDMO biopharmaceuticals, regenerative medicine, pharmaceuticals and cosmetics. Other businesses include graphic systems, highly functional materials, optical devices, imaging, digital imaging and document products. In the year ended March 31, 2017, the company had global revenues of $20.7 billion, at an exchange rate of 112 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com
All product and company names herein may be trademarks of their registered owners.