Fujifilm Diosynth expands fill/finish services for gene therapies and viral vaccines using Vanrx’s SA25 Aseptic Filling Workcell
Fujifilm Diosynth has expanded its fill/finish services for gene therapies and viral vaccines using Vanrx’s SA25 Aseptic Filling Workcell. The SA25 will be installed at Fujifilm’s flexible biomanufacturing facility in College Station, Texas.
Here is the Fujifilm Diosynth news release in its full text:
FUJIFILM ANNOUNCES THE EXPANSION OF ITS FILL/FINISH SERVICES TO INCLUDE LATE PHASE AND COMMERCIAL PRODUCTION OF GENE THERAPIES AND VIRAL VACCINES TO BECOME AN END TO END SOLUTIONS PROVIDER
COLLEGE STATION, Texas, May 23, 2018 ‒ FUJIFILM Diosynth Biotechnologies (Fujifilm), a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and gene therapies, has announced the extension of its gene therapy and viral vaccine Fill/Finish capabilities to provide services in support of late phase candidates and commercial supply. Fujifilm has invested in Vanrx Pharmasystems’ SA25 Aseptic Filling Workcell gloveless isolator technology with automated environmental monitoring and no glass to glass contact.
Fujifilm’s fill finish services offer rapid changeover between drug products and containers, production predictability and the ability to scale up to support commercial production, even when filling and stoppering complex drug products while minimizing defect rates to maximize yield, which is of critical importance when filling very high value products.
“Developers of advanced therapies need to be ready to move swiftly into commercial production, from bulk drug substance and into final dosage form,” said Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, Texas site. “We recognized that having Fill Finish capabilities that extend beyond the current clinical stage is essential to support the rapid delivery of clinical candidates to patients.”
These extended Fill / Finish services will be provided from Fujifilm’s state of the art Flexible Biomanufacturing Facility located in College Station, Texas. This facility is a Center of Excellence for Advanced Therapies production.
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. In addition, 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
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