Anticipating GMP readiness by the end of 2024, the contract development and manufacturing organization (CDMO) will add Cytiva’s SA25 Aseptic Filling Workcell to complete its drug product platform. The workcell will be installed at White Raven's facility in Liège, Belgium.
“With White Raven’s purchase of an SA25 Aseptic Filling Workcell, we continue to expand its installed base – now with more than 60 robotic workcells sold for GMP production purposes. White Raven is now in the position to offer customers aseptic filling capabilities with our technology that reduces contamination risk and improves overall product quality,” Zach Hartman, general manager, aseptic filling for Cytiva told BioProcess Insider.
According to Cytiva, the SA25 Aseptic Filling Workcell is an integrated gloveless robotic isolator capable of filling vials, syringes, and cartridges with batch sizes from 100 up to 20,000 units and a fill volume range of 0.2 - 50 mL.
It offers customers flexibility to move between clinical trial supplies and commercial drugs as well as between different container formats, all within a matter of minutes and days.
Additionally, the SA25’s advanced automation removes the need for human intervention, reducing the risks of errors or contamination. This flexibility is made possible by a single human-machine interface, minimization of change parts, and vapor phase hydrogen peroxide (VPHP) decontamination built as standard.
“Manufacturing efficiency for users is enabled by our ability to provide lead times of 6 months and we repeatedly see customers reaching GMP production within 15 months of placing their purchase order,” said Hartman.
“Typically, competitor systems can take 15 months or longer just to finish a factory acceptance test (FAT), and it can be several additional months after FAT, before GMP operations can actually begin.”
The financials have not been disclosed.
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