We know highly potent APIs.
Purpose-built. Proven. From first API handling to GMP supply.
Where Therapeutic Power Demands Engineering Precision
We are specialists in highly potent active pharmaceutical ingredients — among the most therapeutically valuable and operationally demanding compounds in modern drug development. Active at microgram or nanogram doses, HPAPIs deliver strong clinical effects in oncology, hormonal therapies, and advanced treatment modalities.
That same potency creates two equally important imperatives: protecting operators and preventing cross-contamination. Both require dedicated infrastructure and a structured containment strategy. Standard controls are not sufficient.
Our Pamplona site provides a purpose-built high-containment environment for HPAPI development and GMP manufacturing – from early development through clinical supply and small-scale commercial production.
High Efficacy. Minimal Dose. Dedicated Containment Required.
We work with HPAPIs routinely. These are compounds characterised by exceptional biological activity at very low concentrations — typically with Occupational Exposure Limits at or below 10 µg/m³ (OEB5). Therapeutic doses in the microgram range demand precise manufacturing to ensure dose accuracy, while the same potency means that trace residues present a high cross-contamination risk that must be managed at every step. HPAPIs are most commonly associated with oncology, hormonal therapies, and advanced therapeutics — areas where the trend toward more targeted, more potent molecules continues to accelerate.
Our Pamplona facility. Purpose-built for highly potent compounds.
Facility design features:
- Pressure cascade systems — negative pressure in HPAPI zones ensures airflow is always directed inward, preventing particle migration to adjacent areas
- 100% air renewal — continuous HEPA-filtered fresh air supply with no recirculation; airborne particles are exhausted rather than redistributed
- Airlock systems — validated personnel and material entry and exit procedures that maintain pressure differentials and containment integrity throughout all operations
Engineering. Administration. PPE. In That Order.
Ardena's containment strategy follows the standard hierarchy of controls — prioritising engineering solutions as the primary line of defence, because they function independently of human behaviour and provide the verifiable evidence of containment that regulatory review requires.
Engineering controls
- Closed handling systems and rigid isolators for API weighing, dispensing, and transfer
- Split butterfly valves and contained transfer systems to eliminate dust generation at material transfer points
- Glove boxes and contained processing equipment for direct-interaction operations
- Localised extraction and designed airflow to capture and remove particles at source
Administrative controls
- OEL calculation and Occupational Exposure Band (OEB) classification for each compound before handling begins, reviewed by certified toxicologists — defining containment requirements and cleaning validation residual limits
- Documented procedures for personnel flow, material flow, and cleaning, specific to each OEB level
- Continuous training and environmental monitoring to verify procedural compliance
- Multidisciplinary risk assessment for each new HPAPI project
Personal protective equipment
- Coveralls and respiratory protection appropriate to the OEB classification of the compound
- Enhanced PPE for the highest-potency scenarios, assessed on a compound-specific basis
High-Potency Science, Applied to Oral Solid Dosage Forms
All formulation and process development activities are conducted within the high-containment environment — containment is maintained continuously from first API handling through to finished dosage form, with no transfers to uncontrolled areas at any stage.
Dosage forms
- Uncoated and film-coated tablets
- Hard capsules — powder-filled and multiparticulate formats
Supporting technologies
- Wet and dry granulation for robust HPAPI blend development
- Spray drying for solubility enhancement of poorly soluble highly potent APIs — combining enabling technology and high-potency manufacturing capability at the same site
Containment Planning Starts Before Formulation Does
Each HPAPI project begins with a thorough compound assessment to define containment requirements before any laboratory work commences:
Detailed review of potency, toxicity, and pharmacological data
OEL calculation and OEB classification by certified toxicologists, establishing cleaning limits and acceptable residual levels
Multidisciplinary review across formulation, containment engineering, QA, and toxicology
This upfront assessment ensures the right equipment, procedures, and facility areas are in place from day one — and that containment requirements are never identified too late to influence process design.
Clinical and Commercial Supply
The Pamplona high-containment facility supports GMP manufacturing from Phase I through Phase III clinical supply, and into small-scale commercial production for niche or specialised therapies. The same facility, containment infrastructure, and team carry the programme from development to commercial supply — with no site change and no technology transfer.
Why clients trust us with their most potent molecules.
- Complete product segregation — dedicated suites, pressure cascades, 100% air renewal, and contained transfer systems prevent cross-contamination at every manufacturing step
- Structured OEL/OEB assessment — certified toxicologists and multidisciplinary review define containment and cleaning requirements before any HPAPI handling begins
- End-to-end containment — development and GMP manufacturing within the same high-containment environment, with no transfers to uncontrolled areas
- Spray drying within high containment — enabling technology for poorly soluble HPAPIs available within the Pamplona facility
- Development to commercial continuity — Phase I through small-scale commercial supply at the same site, with a single regulatory filing
- Proven GMP compliance — analytical, QA, and QP infrastructure to support IND, CTA, and NDA/MAA submissions
Related resources
Our expert team members share deep, scientific understanding and insights into manufacturing highly potent and controlled substances.
-
Whitepapers
Innovations in API Manufacturing of Small Molecule Drugs
Read more -
Whitepapers
(Cross-)Contamination Control through Effective Equipment Cleaning
Read more -
Whitepapers
Streamlining Early Drug Development: Efficient Synthesis of Highly Potent Compounds
Read more -
Expert Q&A
Understanding Highly Potent APIs and Safe Handling in Drug Development at Ardena
Read more -
Webinars
On-demand webinar: Navigating highly potent drugs to clinic: best practices from API to drug product
Read more
Small Molecule Development
End-to-end development for small molecules with complex profiles — poorly soluble compounds, highly potent APIs, controlled substances, and challenging physicochemical characteristics. Our scientists know where the problems hide and how to get ahead of them. From first formulation to GMP batch, your program stays in expert hands.
Discuss Your ProgramLarge Molecule Development
Sterile drug product development and manufacturing for biologics and complex parenteral formulations. Our teams are experienced with the sensitivity and precision these molecules demand – from formulation design through aseptic fill-finish and lyophilization. One team that stays with your program.
Discuss Your ProgramNanomedicine Development
Ardena operates one of Europe's broadest nanomedicine platforms – lipid nanoparticles, polymeric nanoparticles, liposomes, nanosuspensions, and beyond. From building block synthesis through GMP production and regulatory submission, we cover the full development arc for nanoparticle-based therapeutics.
Discuss Your Program