
Ardena
We know development. Integrated CDMO and bioanalytical CRO for complex molecules.
Ardena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances. Headquartered in Ghent, Belgium.
Services
- Formulation Development
- Process Development
- CMC Analytical Development
- Oral Solid Dosage Manufacturing
- Inhalation & Nasal Dosage Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- HPAPI Manufacturing (High-Potency)
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- CMC Regulatory Submission Support
- Stability Testing & Storage
- Quality Control Testing
Modalities
Technical specifications & accreditations
Accreditations
Infrastructure
About this organization
Overview
Ardena is an integrated CDMO and bioanalytical CRO built for the complexity of modern drug development. The company specializes in advanced drug product development, nanomedicine, and bioanalysis, working with molecules that present significant challenges to other CDMOs.
Core Capabilities
Drug Product
- End-to-end development for small molecules with complex profiles
- Bioavailability enhancement
- High potency and controlled substance manufacturing
- Oral solid dosage forms
- Sterile injectable formulations
- Clinical trial supply
- Process chemistry and scale-up
- Polymorph and salt screening
- Analytical method development
- GMP manufacturing
Nanomedicine
- Lipid-based nanoparticles
- Polymeric nanoparticles
- Metal nanoparticles
- ADC and XDC development
- CMC regulatory services
Bioanalysis
- Small and large molecule analysis
- Biomarkers
- Immunogenicity testing
- Flow cytometry
- qPCR
- Clinical trial services
- ADC and XDC analysis
Drug Substance
- PROTACs, glues, and conjugates
- Solid state research
- High potent API (HPAPI) synthesis
- CMC regulatory support
Organization
Ardena operates five purpose-built facilities across Europe and the United States, with approximately 700 employees including 350+ scientists and 150+ PhDs. The company has processed 600+ molecules across its portfolio.
Locations
Ghent
Ghent · Belgium
Oss
Oss · Netherlands
Assen
Assen · Netherlands
Pamplona
Pamplona · Spain
Somerset
Somerset · New Jersey · United States
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