[Image courtesy of Ardena]
The approval enables the pharmaceutical CDMO to conduct GMP manufacturing operations for nanomedicines. It follows a €20 million investment in a state-of-the-art 45,000-square-foot facility offering GMP-compliant Grade C and Grade D cleanrooms designed specifically for nanomedicine manufacturing.
Ardena said the site features fit-for-purpose cleanrooms along with additional GMP production spaces. It also has dedicated laboratories for process development and analytical capabilities, plus advanced warehouse facilities.
The expanded capabilities include the manufacturing and GMP release of nanomedicines, Ardena said. These products include advanced nanoparticulate drug delivery systems, as well as imaging agents and tissue engineering products. The facility can handle a wide range of nanomedicines, including lipid-based nanoparticles, polymeric nanoparticles and metal/metal oxide nanoparticles.
Ardena’s Oss facility includes purpose-built automated manufacturing flows and fully integrated analytical capabilities for characterizing complex nanomedicine formulations.
“Achieving full GMP approval for our manufacturing operations is a significant step forward for Ardena,” said Ardena CEO Jeremie Trochu. “This accomplishment underscores our commitment to equipping clients with world-class capabilities for the development and manufacturing of complex nanomedicine formulations. We are proud of our team’s dedication to maintaining the highest regulatory and quality standards.
“Our nanomedicine facility is one of the very few CDMO sites worldwide dedicated exclusively to nanomedicine development and manufacturing. We are uniquely positioned to meet the evolving needs of this fast-growing sector. This achievement exemplifies Ardena’s ability to deliver cutting-edge solutions and support our clients in bringing life-changing therapies to patients.”
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