high potent drug substance synthesis

Ardena specializes in complex organic synthesis and high-potency compound handling under strict containment standards. Facilities are designed to safely process compounds with occupational exposure limits (OELs) below 0.1 µg/m³, ensuring the protection of both personnel and product integrity.

Key strengths include:

• Route scouting and process development for highly potent small molecules.

• Scale-up and GMP manufacturing of APIs for clinical and small commercial supply.

• State-of-the-art containment technologies for safe handling of cytotoxics, oncology APIs, and other high-potency compounds.

• Analytical method development and validation supporting each stage of drug substance production.

• Regulatory expertise, with CMC documentation prepared in parallel to development for smooth dossier submission.

Through this combination of specialized infrastructure, scientific excellence, and regulatory readiness, Ardena is a trusted partner for biopharma innovators developing high-potent drug substances for advanced therapies.