State-of-the-art nanomedicine manufacturing infrastructure

We have recently expanded our site with a brand-new facility that houses cleanrooms and laboratories designed for greater nanomedicine development and manufacturing capacity.

The new facility is fully compliant with the updated EudraLex Annex 1 (EU GMP guidelines) for the Manufacture of Sterile Medicinal Products. It features multiple cleanrooms for processing and final filtration of bulk drug products. The facility features a custom-designed contamination control system, incorporating pressure cascades to prevent microbial contamination while segregating several multi-purpose production rooms. Our fill and finish suite, operational since 2023, is equipped with state-of-the-art class A isolators, facilitating the precise filling of your bulk drug product into vials.

The facility features a custom-designed contamination control system, incorporating pressure cascades to prevent microbial contamination while segregating several multi-purpose production rooms. Additionally, our fill -and finish suite, operational since 2023, is equipped with state-of-the-art class A isolators, facilitating the precise filling of your bulk drug product into vials under aseptic conditions.

Nanomedicine manufacturing often requires a mixture of classic chemical pharmaceutical and biopharmaceutical processes. Ardena’s integrated services provide clients with the synergy that is required for these complex formulations.

Our infrastructure reflects this synergy, uniting:

• Stainless steel and glass-lined chemical reactors (up to 270 L)
• Flow manufacturing technologies
• Tangential flow filtration across wide batch sizes
• Use of pre-sterilized and custom-made single-use assemblies
• Handling of highly potent APIs (HPAPIs)
• Cross-contamination control
• Microbiological contamination control

Our nanomedicine process and manufacturing laboratories feature a diverse array of equipment supporting a wide range of production scales, ensuring seamless translation from bench-top experiments to manufacturing processes. The analytical laboratories are equipped with a multitude of GMP-qualified instrumentation, securing confidence in the release and use of our final products. Moreover, we have several specialized nanoparticle-specific technologies (such as AF4-MALLS) that provide deeper insight into particle formation mechanisms and product characteristics.