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FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities
In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.
FUJIFILM Diosynth Biotechnologies announced on May 23, 2018 the extension of its gene-therapy and viral vaccine fill/finish capabilities to provide services in support of late-phase candidates and commercial supply at the company’s Flexible Biomanufacturing Facility in College Station, TX.
A new Vanrx Pharmasystems’ SA25 Aseptic Filling Workcell gloveless isolator technology with automated environmental monitoring and no glass-to-glass contact enables the company to ensure that its fill/finish services include rapid changeover between drug products and containers, production predictability, and scale up to support commercial production for complex drug products while minimizing defect rates.
“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, in a press release. “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.”