A Site Built Around Nanoparticles
Ardena’s facility in Oss, the Netherlands, is not a general pharmaceutical site that also does nanomedicines. It is a site designed from the ground up for nanoparticle development and manufacturing. The equipment, the analytical infrastructure, the technical expertise, and the quality systems are all configured around the specific demands of LNPs, polymeric nanoparticles, liposomes, and related complex nanotechnology-based products.
That focus matters. The difference between a general injectable site that can manufacture an LNP and a dedicated nanomedicine site is the same as the difference between a GP and a specialist. The specialist has seen the edge cases, solved the unexpected problems, and built the institutional knowledge that makes the process more reliable.
What Oss Offers
LNP Development and GMP Manufacturing
The formulation team at Oss develops LNP products from initial lipid screening through to GMP clinical batch manufacture. Microfluidics and nanoparticle extrusion platforms are available at development and GMP scale, with integrated tangential flow filtration (TFF) capability for buffer exchange and concentration. The site has experience with mRNA, siRNA, and small molecule LNP products across a range of ionisable lipid systems.
Polymeric and Other Nanoparticle Systems
Beyond LNPs, the Oss team has formulation capabilities for PLGA and other biodegradable polymer nanoparticles, nanosuspensions prepared by wet milling, and lipid-polymer hybrid systems. The common thread is that the site is equipped for the characterisation-intensive development work that nanoparticle products require, with DLS, NTA, RiboGreen encapsulation efficiency assays, and in vitro release testing all available in-house.
Analytical Characterisation
The analytical team at Oss provides the full suite of physicochemical characterisation required for LNP and nanoparticle drug product development, including particle size and PDI by DLS, zeta potential, encapsulation efficiency by RiboGreen or equivalent, lipid composition by HPLC, and mRNA integrity by gel electrophoresis. The team develops the analytical methods needed for GMP batch release and regulatory filing alongside the formulation programme.
The Programmes Oss Is Best Suited to Support
| Programme Type | Why Oss Is a Good Fit |
| mRNA LNP therapeutics | Dedicated microfluidics and TFF equipment; mRNA integrity and potency testing; GMP clinical batch capability |
| siRNA or ASO LNP | Nucleic acid encapsulation experience; encapsulation efficiency optimisation; GMP manufacturing at clinical scale |
| Polymeric nanoparticle sustained release | PLGA and polymer nanoparticle development; in vitro release testing; GMP scale-up |
| Nanosuspension for BCS Class II | Wet milling with particle size characterisation; downstream processing to solid dosage form |
| LNP regulatory filing support | Integrated regulatory team; experience with Module 3 CMC for LNP products; familiarity with FDA and EMA expectations |
| Scale-up from development to GMP | Same facility and team at both scales; no formal tech transfer; process parameters maintained consistently |
Connection to the Broader Ardena Network
Oss does not work in isolation. For ADC programmes where the payload requires HPAPI containment, the formulation work at Oss connects with the Pamplona facility’s containment manufacturing capability. For bioanalysis of nanoparticle payloads, Oss works alongside the bioanalytical team at Assen. For aseptic fill-finish of finished nanoparticle drug products, Oss programmes can connect to the sterile manufacturing infrastructure at Ghent.
