Nanomedicine Services

At Ardena, we provide fully integrated nanomedicine solutions, supporting you from preclinical concept to clinic. We specialize in lipid, polymeric, and metal-based nanoparticles, applying deep expertise to design formulations that enhance bioavailability, enable targeted delivery, and improve therapeutic performance. Our Capabilities: - Payloads & API Integration – Incorporation of small molecules, cytotoxics, proteins, peptides, oligonucleotides, and mRNA/DNA using encapsulation, bioconjugation, coating, and surface modification. - Custom Building Blocks – In-house synthesis of lipids, monomers, polymers, and inorganic complexes for tailored nanoparticle design. - Process Development & Scale-Up – Phase-appropriate, cGMP-compliant processes supported by microfluidics, tangential flow filtration, spray drying, and single-use systems, with safe handling of highly potent APIs. - Manufacturing Infrastructure – Our new Oss facility includes Annex 1-compliant cleanrooms, automated workflows, high-containment capabilities, and reactors up to 270 L for robust, scalable production. - Aseptic Fill-Finish & Clinical Supply – Closed isolators enable precision vial filling, labeling, kit assembly, and secure clinical trial logistics. - Analytical & Stability Expertise – Advanced nanoparticle characterization (DLS, AF4-MALS, SAXS, NMR) combined with ICH-guided stability studies ensure product quality. - Bioanalytical Capabilities – Evaluation of pharmacokinetics, biodistribution, and release profiles using advanced platforms to deliver submission-ready data. - Regulatory & Program Support – Phase-appropriate CMC strategies and expert guidance streamline submissions and reduce risk. With over a decade of experience, Ardena combines scientific rigor and manufacturing excellence. Our integrated approach and new nanomedicine facility enable high-quality, phase-appropriate solutions, ensuring a smooth path from concept to clinic.