Ardena Secures GMP Approval for Nanomedicine Facility in Oss

• Ardena has received full Good Manufacturing Practice (GMP) approval for its expanded nanomedicine facility in Oss, the Netherlands.

• The €20 million investment in the 45,000 sqft facility enhances Ardena’s capacity for the manufacturing of complex nanomedicine formulations, including lipid-based and polymeric nanoparticles.

Ardena, a pharmaceutical Contract Development and Manufacturing Organisation (CDMO), has announced the full GMP approval of its newly expanded nanomedicine manufacturing facility in Oss. This approval, granted by the Dutch Healthcare Authority, is a significant milestone for the company in its commitment to supporting the development of innovative nanomedicines.

The expansion follows a €20 million investment in the 45,000 sqft facility, which features state-of-the-art Grade C and Grade D cleanrooms specifically designed for nanomedicine production. The facility is now fully equipped to manufacture advanced nanoparticulate drug delivery systems, imaging agents, and tissue engineering products under GMP conditions. The approval includes the manufacturing and GMP release of lipid-based nanoparticles, polymeric nanoparticles, and metal-based nanoparticles.

CEO Jeremie Trochu expressed his pride in the achievement: “This accomplishment underscores our commitment to equipping clients with world-class capabilities for the development and manufacturing of complex nanomedicine formulations,” he said. The facility also features automated manufacturing flows and integrated analytical capabilities to ensure high-quality, productive operations.

Ardena’s new nanomedicine manufacturing facility is one of the few CDMO sites globally dedicated exclusively to nanomedicine development. The company’s integrated service offering includes aseptic fill-finish capabilities and bioanalysis expertise, providing end-to-end support for clinical supply, especially for injectable nanomedicine formulations.