Recent gene therapy approvals have driven the demand for third-party services, says Fujifilm as it expands fill & finish capabilities at its recently opened site.
In January 2018, Fujifilm Diosynth Biotechnologies opened an 80,000 sq-ft facility in College Station, Texas, for the manufacture of gene therapies.
This week, the contract development and manufacturing organization (CDMO) has expanded the plant to support the fill & finish of Phase III and commercial products by adding a Vanrx Pharmasystems’ SA25 automated filler.
“We already have Fill/Finish capabilities in place but the current capabilities are limited to early phase,” said Gerry Farrell, chief operating officer at the College Station site. “The new automated filler will allow us to be ready to provide Fill/Finish services for phase 3 commercial.”
Farrell told BioProcess Insider the added technology came off the back of client demand, encouraged by the approval of Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) last year.
“As the gene therapies show tremendous promise, with the first three gene therapies gaining US FDA approval in the US just last year and many candidates in clinical trials, we expect the demand for commercial gene therapy production to increase. The driving factor of this offering is to support developers of advanced therapies to move them swiftly into commercial production.”
Extra Layers of Protection
Gene therapy manufacturing yields a product that is a viral vector, rather than recombinant protein manufacturing, which yields a product that has function (i.e. the protein).
These vectors are specifically designed to target the human body, and so the manufacturing process is different, including fill & finish process.
The process needs to have extra layers of protection, Farrell said, “both for the operators as well as the product itself. For that reason, we are installing a touchless filling system enclosed in an isolator with an in-built sanitization system.”
Once operational – the filler is expected to be fully validated by the end of October – Fujifilm will 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.”
This is of critical importance when filling very high value products, Farrell said, adding: “While the production capacity will depend on the vial size, we can supply enough vials for commercial production.”