Process development, analytical development, analysis, stability testing, manufacturing
Crystal structure by X-ray, solid form screening, solid form selection, IP support
Formulation development, analytical development, manufacturing, stability studies
Packaging, labeling, clinical trial logistics
Mass spectrometry, immunochemistry, flow cytometry, in-vitro drug discovery, clinical trial services
Scientific report writing, module 3 writing, regulatory CMC support
Guiding your nanomedicine candidate through its journey to the clinic
Developing and manufacturing formulations that lead to improved bioavailability
Meeting your needs from pre-clinical to small-scale commercial manufacturing
Bringing your oral drug to clinical trials quickly and reliably
Guiding you through the development of injectable drug products to GMP standards
Enhancing biomolecule purity with tailored solutions for GMP-grade materials at scale
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Helping you turn your compounds that show promise into GMP-grade drug substances.
We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.
We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.
Always agile, we reliably guide you and your molecule through the challenging terrain of early phase development
Carefully engineered to support and enable early phase development for our partners’ oral drugs, injectables and nanomedicines
Our leadership team has a deep scientific understanding combined with exceptional experience
Platforms and facilities that are uniquely engineered to support and enable integrated early phase development
We’re a fast-growing EU-based company with many opportunities for you to grow and progress with us
The focus on drug discovery has been shifted from the traditional small molecules to biologics and new modalities as a result of increasing research to address unmet medical needs. This evolution requires drug delivery technologies capable of carrying the drug intact to specific sites in the body and across cellular membranes to reach their targets. Engineered nanoparticles have emerged over the past decades as effective and customizable drug delivery platforms.
Due to the versatility of nanoparticulate systems they are defined broadly as materials engineered with at least one dimension or structure in the range of 1–100 nm or as particles with properties related to their nanoscale dimension, even if this dimension is up to 1 μm. In Ardena we define nanoparticles as having a size up to 200 nm. While the concept of entrapping the drug in nanoparticles has been known for many years, the increasing mechanistic understanding and constant advances in optimizing nanoparticulate drug delivery technologies for specific applications continues to accelerate the progress and use in drug product development .
Specific regulatory pathways to stimulate nanoparticle-based drug delivery systems have been drafted by regulatory authorities providing meaningful guidance for research, development, and manufacturing. With the outbreak of the pandemic, the successful development and emergency use of mRNA lipid nanoparticulate vaccines in record time was a quantum leap forward for nanoparticle drug delivery technology. This encouraged drug developers to intensify their investments in engineered nanoparticle delivery for innovative therapeutics approaches.
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