FDF / DRUG PRODUCTS SERVICES in Europe
Drug product formulation development and GMP manufacturing (clinical phase)
About the plant
Overview of the Ardena CDMO Site in Gent
Ardena is a global Contract Development and Manufacturing Organization (CDMO) and bioanalytical partner that supports biopharmaceutical companies in advancing drug candidates from early-phase development through clinical supply and regulatory filing. The company’s headquarters and one of its core operational hubs is located in Gent (Mariakerke), Belgium — a site of strategic importance for drug product development, clinical supply logistics, and regulatory support. Ardena
At this Gent site, Ardena combines scientific expertise, GMP-compliant facilities, and multidisciplinary teams to serve clients ranging from small biotech innovators to larger pharmaceutical companies. Ardena
Core Expertise & Capabilities at the Gent Site
1. Drug Product Development & Manufacturing (Clinical Phase)
The Gent site is a center of excellence for drug product services, especially focused on supporting clinical trial material manufacture for both oral and injectable drugs. Ardena
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Formulation development — Designing and optimizing formulations to ensure appropriate drug delivery and stability for clinical testing. Ardena
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GMP manufacturing suites — Facilities capable of producing clinical batches under regulatory standards, including aseptic fill-finish for sterile products (e.g., parenterals) following recent GMP licensure of its aseptic fill-finish plant in Ghent, enhancing capacity for oligonucleotides, peptides, proteins, and biologics. Ardena
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Analytical method development — In-house analytical support to characterize product quality attributes, assisting in formulation decisions and QC release testing files. Ardena
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Support for small clinical batch sizes — The site’s flexible manufacturing approach is well-suited to early-phase clinical programs or personalized/complex therapies where batch volumes are limited. Ardena
2. Comprehensive Clinical Supply & Logistics
A critical operational capability of the Gent facility is the orchestration of clinical logistics and supply chain management for investigational products:
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Packaging & labeling — Ensuring compliance with clinical trial requirements and regulatory labeling standards. Ardena
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Clinical logistics — Handling storage, distribution planning, and global shipment of clinical trial materials to sites across regions. Ardena
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Randomization & kit assembly — Supporting study designs requiring blinded or complex treatment packaging. Ardena
This integrated supply function helps streamline operations for sponsors, particularly when rapid turnaround and global distribution are required. Ardena
3. CMC Regulatory Support & Documentation Expertise
The Gent site also houses Ardena’s CMC (Chemistry, Manufacturing and Controls) regulatory team, which provides scientific and regulatory writing support to clients preparing submission dossiers for clinical application. Ardena
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Regulatory strategy development — Advising on dossier requirements at different clinical phases. Ardena
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Documentation compilation — Preparing and structuring regulatory modules, ensuring alignment with global standards (e.g., ICH). Ardena
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Quality systems & compliance oversight — Ensuring that all processes align with current GMP, GLP and regulatory expectations throughout development. Ardena
This expertise is vital in reducing regulatory risk and accelerating approval processes. Ardena
4. Integrated & Cross-Functional Collaboration Platform
Gent functions as an integration hub, collaborating with Ardena’s other specialized sites across Europe to provide end-to-end support: Ardena
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Bioanalytical services (from sites in Netherlands) — analysis of biomarkers, quantitation, and method validation to support preclinical and clinical studies. Ardena
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Drug substance and solid state research (Oss, Netherlands) — API scale-up and characterization supporting product formulation streams. Ardena
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Nanomedicine capabilities (Oss) — advanced delivery systems integrated for injectable formulations. Ardena
This cross-site synergy enables Ardena to act as a single-source partner in the clinical development chain. Ardena
Strategic Positioning of the Gent Site
The Gent facility’s positioning as both a headquarters and operational center reflects Ardena’s commitment to high-quality, flexible, phase-appropriate clinical support. Its multidisciplinary team of scientists, regulatory specialists, and manufacturing experts work together to de-risk development pathways, shorten timelines, and ensure regulatory compliance — particularly during early and mid-stage clinical phases. Ardena
Summary of Key Strengths at Ardena Gent
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Clinical drug product expertise — from formulation to GMP manufacture for diverse modalities. Ardena
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Aseptic fill-finish capacity with GMP license — supporting novel injectables. Ardena
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Integrated clinical logistics & supply chain management, including packaging and distribution. Ardena
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CMC regulatory support & dossier preparation for submissions. Ardena
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Collaboration hub linking cross-site scientific capabilities across Ardena’s European network.
Certifications
- EMA (EU GMP)
- French Service-Public (CIR)
- ECOVADIS
Activity
- Inhalation products, Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Aerosol, Powder, Nebulization, Bottles, Tubes, Sprays, Bulk, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Oral foams, Tablets, Hard capsules, Granules / Pellets, Powders, Lyophilizates, Terminal sterilization, Fill&Finish, Semisolid forms, Liquid forms, Rectal and vaginal dosage forms, Small volume vials, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
- Controlled substance: High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Formulation mixing, Lyophilization, Research batches, Engineering batches, Pilot batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support
