Ardena | Ardena Gent

Overview of the CDMO Site in Belgium

This site is part of 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 headquarters and one of its core operational hubs is located in Belgium — a site of strategic importance for drug product development, clinical supply logistics, and regulatory support.

At this site, the organization combines scientific expertise, GMP-compliant facilities, and multidisciplinary teams to serve clients ranging from small biotech innovators to larger pharmaceutical companies.

Core Expertise & Capabilities at the Gent Site

1. Drug Product Development & Manufacturing (Clinical Phase)

The site is a center of excellence for drug product services, especially focused on supporting clinical trial material manufacture for both oral and injectable drugs.

• Formulation development — Designing and optimizing formulations to ensure appropriate drug delivery and stability for clinical testing.
• GMP manufacturing suites — Facilities capable of producing clinical batches under regulatory standards, including aseptic fill-finish for sterile products (e.g., parenterals), enhancing capacity for oligonucleotides, peptides, proteins, and biologics.
• Analytical method development — In-house analytical support to characterize product quality attributes, assisting in formulation decisions and QC release testing files.
• Support for small clinical batch sizes — A flexible manufacturing approach well-suited to early-phase clinical programs or personalized and complex therapies where batch volumes are limited.

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:

• Packaging & labeling — Ensuring compliance with clinical trial requirements and regulatory labeling standards.
• Clinical logistics — Handling storage, distribution planning, and global shipment of clinical trial materials to sites across regions.
• Randomization & kit assembly — Supporting study designs requiring blinded or complex treatment packaging.

This integrated supply function helps streamline operations for sponsors, particularly when rapid turnaround and global distribution are required.

3. CMC Regulatory Support & Documentation Expertise

The Gent site also houses a dedicated CMC (Chemistry, Manufacturing and Controls) regulatory team, which provides scientific and regulatory writing support to clients preparing submission dossiers for clinical applications.

• Regulatory strategy development — Advising on dossier requirements at different clinical phases.
• Documentation compilation — Preparing and structuring regulatory modules, ensuring alignment with global standards (e.g., ICH).
• Quality systems & compliance oversight — Ensuring that all processes align with current GMP, GLP, and regulatory expectations throughout development.

This expertise is vital in reducing regulatory risk and accelerating approval processes.

4. Integrated & Cross-Functional Collaboration Platform

The site functions as an integration hub, collaborating with other specialized sites across Europe to provide end-to-end support:

• Bioanalytical services — Analysis of biomarkers, quantitation, and method validation to support preclinical and clinical studies.
• Drug substance and solid state research — API scale-up and characterization supporting product formulation streams.
• Nanomedicine capabilities — Advanced delivery systems integrated for injectable formulations.

This cross-site synergy enables the organization to act as a single-source partner in the clinical development chain.

Strategic Positioning of the Site

The facility positions as both a headquarters and operational center reflects a commitment to high-quality, flexible, phase-appropriate clinical support. A 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.

Summary of Key Strengths at the Site

• Clinical drug product expertise — from formulation to GMP manufacture for diverse modalities.
• Aseptic fill-finish capacity with GMP license — supporting novel injectables.
• Integrated clinical logistics & supply chain management, including packaging and distribution.
• CMC regulatory support & dossier preparation for submissions.
• Collaboration hub linking cross-site scientific capabilities across a European network.