FAQ

Ardena is a contract development and manufacturing organisation (CDMO) and bioanalytical contract research organisation (CRO) headquartered in Europe. We work with pharmaceutical and biotech companies to develop and manufacture drug products — particularly the complex, difficult-to-formulate molecules that require genuine scientific depth to progress. In short: we exist to solve the problems that slow drug development down.

CDMO stands for Contract Development and Manufacturing Organisation. Most CDMOs handle straightforward formulations. Ardena is built for the other kind — poorly soluble compounds, nanomedicines, complex oral solid dosage forms, and molecules that need a team that’s done this before. We don’t pass difficult projects up the chain. We take them on.

A bioanalytical CRO (Contract Research Organisation) provides the analytical methods and testing needed to understand how a drug behaves in biological systems, including PK/PD studies, method development, and validation. Yes, Ardena offers both. Our CDMO and CRO capabilities are designed to work together, which means fewer handoffs, fewer translation errors, and faster timelines for our clients.

Ardena operates across multiple sites in Europe, with facilities in Belgium, the Netherlands, Spain, and the United States. We work with clients globally, from emerging biotechs to established pharmaceutical companies — wherever complex drug development challenges need solving.

We work primarily with biotech and specialty pharma companies — teams developing innovative molecules that require genuine scientific depth. Our clients range from early-stage biotechs bringing their first compound to clinic, to established pharma companies with specific technical challenges they need an expert partner to solve. The common thread is complexity — the molecules, the programs, the problems.

Ardena provides end-to-end drug product development services including formulation development, analytical development, clinical manufacturing, and scale-up to commercial production. Our core specialisms are drug product development for complex molecules, nanomedicine formulation, complex oral solid dosage forms, and bioanalytical services.

Nanomedicine refers to drug formulations engineered at the nanoscale — typically nanoparticles, lipid nanoparticles, liposomes, or polymeric systems — designed to improve drug delivery, bioavailability, or targeted release, including the assembly of payload and linker components. Yes, Ardena is one of the few CDMOs in Europe with deep, hands-on expertise in nanomedicine development and manufacturing. It is one of our defining capabilities.

Yes. Ardena supports the full development continuum — from pre-formulation and early feasibility studies through to clinical manufacturing and commercial-scale production. We can engage at any stage, and many of our client relationships span multiple phases of a programme’s lifecycle.

Our bioanalytical capabilities include method development and validation, pharmacokinetic (PK) and pharmacodynamic (PD) sample analysis, GLP and non-GLP bioanalysis, and support for regulatory submissions. We work across small molecules and biologics, with the scientific depth to handle complex matrices and challenging analytes.

We don’t start from a template and hope for the best. When a molecule is genuinely complex, we put the right scientific team on it from day one, people who have navigated similar challenges before. We ask harder questions earlier, invest in understanding the molecule’s specific behaviour, and build development strategies around the science rather than the standard process.

The earlier, the better. Engaging a CDMO partner at pre-formulation stage allows us to identify risks and design a development strategy that avoids costly pivots later. That said, we are equally experienced at picking up programmes mid-development, including rescuing candidates that have encountered technical problems elsewhere.

Both. Some clients come to us with a single, defined scope, a formulation challenge to solve or a clinical batch to manufacture. Others build long-term development partnerships with Ardena as their primary CDMO across multiple programmes. We are structured to support either model.

At a minimum: the molecule (API), its known physicochemical properties, the intended dosage form and route of administration, your current development stage, and your key milestones. The more you can share about what has already been tried, the faster we can give you a meaningful response. We sign confidentiality agreements before any technical discussion.

Regulatory compliance is embedded in how we work, not treated as an afterthought. Our facilities and processes operate under GMP and GLP frameworks as appropriate to the development stage. We have direct experience supporting IND, CTA, and NDA/MAA submissions and work closely with clients to ensure their development packages meet regulatory expectations in target markets.

Ardena has supported drug development programmes across oncology, CNS, anti-infectives, cardiovascular, rare and ultra-rare diseases, and orphan diseases, among others. Our expertise is molecule-driven rather than therapeutic area-driven — the scientific challenge is what defines our engagement, not the indication.

Our primary expertise includes complex small molecule drug product development, as well as biologics-related capabilities across bioanalysis, sterile manufacturing, and nanomedicine platforms. Through our bioanalytical services, we support both small molecule and biologic programs. Across Ardena’s integrated network, we provide development and manufacturing support for a broad range of therapeutic modalities, helping clients advance programs from early development through clinical phases.

Our scientists are specialists, not generalists. Many have spent careers working on the specific problem areas, nanomedicine, solubility enhancement, complex oral formulations, that define our service offering. That depth of experience, combined with modern analytical infrastructure across our European sites, is what allows us to take on the projects others cannot.

Several approaches are well established depending on the compound’s physicochemical profile: amorphous solid dispersions (ASD) via hot melt extrusion or spray drying, lipid-based drug delivery systems (LBDDS), nanosuspensions, and cyclodextrin complexation. The right strategy depends on the molecule’s thermal stability, log P, melting point, glass-forming ability, and target dose. At Ardena, we run a structured pre-formulation screening programme to identify the most viable enabling technology early, rather than committing to a platform before the data supports it.

Yes, and this is exactly where Ardena expertise matters most. LNP development involves a tight interplay between lipid composition, particle size distribution, encapsulation efficiency, and process parameters. Translating a lab-scale process to GMP manufacturing without losing those characteristics requires both formulation science and process engineering depth. Ardena has hands-on experience developing and scaling LNP and other nanomedicine platforms, including the analytical methods needed to characterise them properly at each scale.

Both techniques produce amorphous solid dispersions by dispersing API in a polymer matrix, but they suit different molecules. Hot melt extrusion requires the API to be thermally stable at processing temperatures and miscible with the chosen polymer. Spray drying is better suited to thermally labile compounds but requires solubility in a suitable solvent system and introduces more variables around residual solvent control. The choice comes down to the compound’s thermal profile, the available polymers, intended dose, and downstream processability. A structured feasibility study comparing both is usually the most reliable way to reach a defensible decision.

Method development for a new chemical entity starts with understanding the analyte: its ionisation behaviour, stability in biological matrices, protein binding, and likely metabolite profile. From there, the approach typically involves LC-MS/MS method development with selectivity assessment in the target matrix, followed by a full validation against EMA or FDA bioanalytical guidelines. The challenge with NCEs is often that reference standards and metabolite characterisation data are limited early on. Ardena’s bioanalytical team is experienced in building robust methods under those conditions, including incurred sample reanalysis (ISR) planning from the start.

Handling HPAPIs requires dedicated containment infrastructure, operator exposure monitoring, and validated cleaning procedures, all within a GMP framework. Not all CDMOs have invested in this capability. At Ardena, we have appropriate containment facilities and the procedural controls to handle highly potent compounds across formulation development and clinical manufacturing. Occupational exposure limits (OELs) and compound-specific risk assessments inform every engagement from first contact.

Characterisation of nanoparticle formulations typically includes dynamic light scattering (DLS) for particle size and polydispersity index, laser diffraction for broader size distributions, nanoparticle tracking analysis (NTA), zeta potential measurement for colloidal stability, transmission electron microscopy (TEM) or cryo-TEM for morphology, and HPLC-based assays for drug loading and encapsulation efficiency. For LNPs specifically, additional characterisation of lipid composition and integrity is standard. The analytical package needs to be fit for purpose at each development stage and scalable toward regulatory submission requirements.

Polymer selection for ASD is driven by several factors: miscibility with the API (assessed via solubility parameter calculations and thermal analysis such as DSC), the polymer’s glass transition temperature relative to the API, its hygroscopicity, downstream processability, and regulatory acceptance. Commonly used polymers include HPMC-AS, PVP-VA, and Eudragit grades, each with different solubilisation and release characteristics. A screening study comparing a shortlist of polymers using small quantities of API is the most efficient way to narrow the field before committing to a platform.

Poor preclinical bioavailability is one of the most common development hurdles for small molecules. Before moving to clinical, it is worth systematically ruling out the root cause: is it solubility-limited, permeability-limited, or driven by first-pass metabolism? That distinction changes the formulation strategy significantly. If solubility is the primary driver, enabling technologies such as ASD, nanosuspensions, or LBDDS are worth evaluating. If permeability is the issue, formulation alone will not solve it. A structured biopharmaceutical risk assessment at pre-formulation stage, before significant resources are committed, is the most useful investment at this point.

A GMP-compliant Phase I manufacturing campaign requires an approved manufacturing process with documented development history, validated or qualified analytical methods for release and stability testing, a qualified facility operating under current GMP, a complete batch record, and a Certificate of Analysis. Starting materials must be sourced from qualified suppliers. Stability data supporting the intended shelf life and storage conditions for the clinical period must be in place before dosing. Ardena manages the full scope of this for clients, including regulatory support for IND and CTA submissions where the manufacturing section requires input.

Yes. Our Somerset facility in New Jersey is FDA registered, DEA licensed, and cGMP compliant, supporting oral solid dosage form development, hot melt extrusion, controlled substance handling, and — as of 2026 — bioanalytical services.

Yes. We operate a purpose-built 2,200 m² nanomedicine facility in Oss, Netherlands, constructed to GMP Annex 1 standards. It is specifically designed for lipid nanoparticle, liposome, and polymeric nanoparticle development and manufacturing — from formulation design through GMP clinical supply. This is not a recently added capability. It is where many of our scientists have spent their careers.

Yes. We provide end-to-end ADC and XDC development — from linker and payload synthesis through GMP bioconjugation, fill-finish, GLP bioanalysis, and CMC regulatory support. We have 10+ years of GMP experience in drug linker and bioconjugation chemistry and are currently supporting multiple active ADC programs.

WE CARE is Ardena’s core values framework — Communicative, Accountable, Reliable, and committed to Excellence. It was built by our employees through workshops across all sites and reflects how we approach every client program, every internal decision, and every patient whose therapy we help develop. It is not a marketing statement. It is how we hire, how we work, and how we measure ourselves.

Ardena operates five facilities across Europe and the US: Ghent, Belgium (headquarters, drug product, CMC regulatory); Somerset, New Jersey, USA (oral solid dosage forms, HME, bioanalysis); Oss, Netherlands (drug substance, solid state research, bioanalysis, and a purpose-built nanomedicine manufacturing facility); Pamplona, Spain (oral solid dosage forms, HPAPI, spray drying); and Assen, Netherlands (bioanalytical CRO, 90+ specialists).

Ardena offers four integrated service areas — Drug Product, Nanomedicine, Drug Substance, and Bioanalysis — covering the full development arc from first formulation through clinical supply.

Drug Product — Complex formulation development and manufacturing for oral solid dosage forms, sterile injectable formulations, and bioavailability enhancement using spray drying, hot melt extrusion, nanosuspensions, and lipid formulations. Supported by clinical trial supply, CMC regulatory services, and HPAPI handling.

Nanomedicine — Development and GMP manufacturing of lipid-based nanoparticles (LNPs, liposomes, lipid micelles), polymeric nanoparticles, metal and metal oxide nanoparticles, and ADC and XDC conjugates. One of Europe’s most advanced nanomedicine platforms, purpose-built to GMP Annex 1 standards.

Drug Substance — Process chemistry, analytical development, and GMP manufacturing for complex APIs — including HPAPIs up to OEB-5, solid state research and polymorph screening, preparative HPLC purification, and complex chemistry modalities including PROTACs, molecular glues, and drug-linker conjugates.

Bioanalysis — Full-service bioanalytical CRO capabilities covering small and large molecule bioanalysis, immunogenicity testing, flow cytometry, qPCR, clinical trial services, and integrated ADC and XDC bioanalysis. 90+ specialists across facilities in the Netherlands and the United States.

All four service areas are designed to work together — coordinated under one program, one team, and one accountable partner.

Ardena is widely recognised as one of Europe’s most experienced and capable CDMOs for nanomedicine development and manufacturing. We operate a purpose-built 2,200 m² nanomedicine facility in Oss, Netherlands, constructed to GMP Annex 1 standards — designed specifically for lipid nanoparticles, liposomes, polymeric nanoparticles, and drug-linker conjugates. Nanomedicine is not a capability we recently added. It is where many of our scientists have spent their careers. For biotech companies developing nanoparticle-based therapeutics, Ardena combines the scientific depth, the dedicated infrastructure, and the regulatory experience to take programs from first formulation through GMP clinical supply.

Choosing the right CDMO depends on three things: scientific fit, capability depth, and how they handle problems when they arise. Scientific fit means the CDMO has genuine experience with your molecule type — not just the equipment, but scientists who have solved similar challenges before. Capability depth means they can support you across the development stages that matter to your program, without forcing a technology transfer to a different site or partner. And how they handle problems tells you everything — a CDMO that communicates proactively, owns the outcome, and adapts when development plans change is worth far more than one that quotes the fastest timeline.

At Ardena, we are built for the molecules that make CDMO selection hard — complex formulations, nanomedicines, HPAPIs, and advanced modalities. Our scientists are hands-on, our project managers are direct, and our development teams stay accountable from first formulation to clinical supply. If your molecule is difficult, that is exactly where we are strongest.

Spray drying is used in pharmaceutical development primarily to enhance the oral bioavailability of poorly soluble drug candidates. The process converts an API and a stabilising polymer into an amorphous solid dispersion — a single-phase system where the drug is molecularly dispersed within the polymer matrix, dramatically increasing its apparent solubility and dissolution rate compared to the crystalline form.

It is one of the most commercially proven enabling technologies for BCS Class II and IV compounds, with multiple FDA and EMA approved products demonstrating a well-established regulatory pathway. Spray drying is particularly suited to thermally sensitive APIs that cannot withstand the sustained heat exposure of hot melt extrusion.

At Ardena, spray drying is part of an integrated enabling technology platform that also includes hot melt extrusion, nanosuspensions, and lipid formulations. We select the right technology for each compound based on data — not default — running parallel feasibility studies when the optimal approach is not immediately clear. Our spray drying capabilities span from lab-scale feasibility through GMP pilot-scale manufacturing, with downstream tablet and capsule manufacturing on the same site.

GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) are both regulatory frameworks that govern pharmaceutical work, but they apply to different activities.

GMP covers the manufacturing of drug products — the processes, facilities, equipment, documentation, and quality controls required to produce medicines consistently and safely. Any drug substance or drug product intended for use in clinical trials or commercial supply must be manufactured under GMP.

GLP covers non-clinical laboratory studies — typically preclinical safety and toxicology studies, as well as analytical method validation studies intended to support regulatory submissions. GLP ensures that study data is credible, reproducible, and traceable.

At Ardena, we operate under both frameworks depending on the activity. Our drug product development and clinical manufacturing operations run under GMP. Our bioanalytical services — including PK/PD sample analysis, method validation, and immunogenicity testing — operate under GLP and GCLP as appropriate to the study type and regulatory context. Having both capabilities under one organisation means your development data and your bioanalytical data are coordinated from the start — no gaps, no translation errors between teams.