Ardena, a specialist pharmaceutical Contract Development and Manufacturing Organisation (CDMO) with GMP facilities in Belgium, Spain, the Netherlands, and Sweden, has announced the full Good Manufacturing Practice (GMP) approval of its expanded nanomedicine facility in Oss, Netherlands. Granted by the Dutch Healthcare Authority, the approval enables GMP manufacturing operations for nanomedicines, marking a milestone in Ardena’s mission to support clients in bringing innovative therapies to clinic and to market.

The approval follows a €20 million investment in a 45,000 square foot facility offering GMP-compliant Grade C and Grade D cleanrooms designed specifically for nanomedicine manufacturing. The fit-for-purpose cleanrooms, alongside additional GMP production spaces, dedicated laboratories for process development and analytical capabilities, and advanced warehouse facilities, come as part of Ardena’s commitment to meeting stringent regulatory standards, including the latest updates to Annex 1 for the manufacture of sterile products.

Ardena’s expanded capabilities now include the manufacturing and GMP release of nanomedicines, covering lipid-based, polymeric, and metal/metal oxide nanoparticles. The Oss facility features automated manufacturing, integrated analytical tools for complex formulations, and scalability.