Fujifilm Diosynth Biotechnologies (Fujifilm), a contract development and manufacturing organization (CDMO) with experience in 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.
The 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 flexible biomanufacturing facility located in College Station, TX. The facility is a Center of Excellence for Advanced Therapies production.
(Source: Fujifilm Diosynth Biotechnologies)
