Ardena Capabilities Update May 2026: Highly Potent Drug Development & Manufacturing

High-potent compounds are no longer a niche — they are a defining feature of modern drug development pipelines. This presentation from ADENA outlines how an integrated CDMO/CRO model, built around science-led, phase-appropriate, and dossier-centric principles, can manage the full complexity of high-potent development from drug substance through to commercial drug product.

Arno Vermote, Ph.D., Director of Business Development, covers ADENA's structured approach to risk assessment and OEL-driven control strategies, facility design for containment, cleaning validation as a core safety pillar, and the role of ultra-sensitive analytical methods — with limits of quantification reaching 1.3 nanograms per square centimeter. Capabilities, including spray drying, granulation, tableting, capsule filling, and primary packaging, are discussed in the context of maintaining containment integrity across every manufacturing step.

ADENA's EU and US network supports compounds up to OEB5, with regulatory inspection history across both regions.