CDMO Ardena has received full Good Manufacturing Practice (GMP) approval for its expanded nanomedicine manufacturing facility in Oss, the Netherlands.
Through the Dutch Healthcare Authority's go-ahead, GMP manufacturing can now occur at the site, allowing the company to further support its clientele in producing lipid-based, metal and polymeric nanoparticles.
This approval follows Ardena's €20m investment, which was spent on installing Grade C and D cleanrooms designed specifically for nanomedicine manufacturing.
The facility currently has process development, analytical and storage capabilities, and is Annex 1 compliant.
Additionally, Ardena's Oss facility incorporates atuomation into its manufacturing flows, as well as integrated nanomedicinal formulation characterisation.
By utilising these technologies, the company can produce complex nanoparticles such as LNPs, liposomes, lipid micelles, polymer micelles, dendrimer-based nanoparticles and gold/silica/iron oxide nanoparticles.
Jeremie Trochu, CEO of Ardena, commented: “Achieving full GMP approval for our manufacturing operations is a significant step forward for Ardena. 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. It's fully integrated and includes aspetic fill/finish capabilities, as well as bioanalysis expertise. With these capabilities we can offer end-to-end support for clinical supply — a strong advantage for injectable nanomedicine formulations.”