The contract development and manufacturing organisation (CDMO) announced the opening of its Flexible Manufacturing Facility (FBF) in College Station, Texas last week, offering customers clinical and commercial gene therapy production.
The space is a standalone facility within Fujifilm’s Texas site – acquired from Kalon Therapeutics in 2014 – and according to Andy Fenny, SVP global S&OP and program management at Fujifilm Diosynth Biotechnologies, uses mobile clean room technology for multiproduct production of advanced therapies.
“The gene therapy space is rapidly growing thanks to developments in the technology over the past 20 years. We are seeing more and more companies focusing on this space,” he told Biopharma-Reporter.
“With recent successes in approvals and seeing more candidates receiving Breakthrough status the needs for CDMOs with Commercial Production capacity and expertise is higher than ever.”
His words echo those of fellow CDMO Paragon Bioservices, which earlier this month said a planned 150,000 square-foot facility in Maryland would support “the growing need for broad gene therapy manufacturing capacity.”
Fujifilm has also completed the qualification of three 2,000L single-use bioreactors at its ‘Saturn’ mammalian cell culture facility at the Texas site, enabling the start of cGMP operations.
“The Saturn mAb Manufacturing Facility is equipped with 2,000L single-use bioreactor trains,” Fenny told us. “Investment to date is for six bioreactors but the facility is designed to accommodate up to 12 with the ability to expand further if necessary.”
While Fenny did not disclose how much of this new capacity has been earmarked for use by current customers, he said Fujifilm is “well positioned to meet the growing demands.”
“The facility is designed to be high throughput exploiting our platform Saturn process and the ability to readily expand therefore we have positioned ourselves to rapidly respond to the growing demands of the market or respond to client specific high demand.”