Drug Substance Services

At Ardena, we provide integrated drug substance development and manufacturing solutions to help you move from discovery to clinical supply and beyond. Our expertise spans the entire lifecycle, from route scouting and process optimization to GMP manufacturing of small molecules and complex APIs, including high potency compounds. Our scientists work as an extension of your team, focusing on developing scalable, robust, and regulatory-compliant processes tailored to your molecule’s unique characteristics. We combine deep technical know-how with flexibility to meet your project’s specific requirements and timelines. Our capabilities include: - Process & Route Development – Efficient and scalable synthetic routes designed to maximize yield, safety, and reproducibility. - High Potency API Handling – Dedicated facilities, specialized equipment, and strict containment procedures to safely develop and manufacture highly potent compounds. - GMP Manufacturing – From gram-scale clinical supply to multi-kilogram commercial production, ensuring quality and compliance at every stage. . Crystallization & Solid-State Expertise – Control of polymorphism, particle size, and morphology to ensure optimal performance of your API. - Analytical Development & Validation – Comprehensive in-house capabilities to support every stage of development, from method design to QC testing. - Technology Transfer – Smooth transitions from development to manufacturing, with scalable processes designed for long-term reliability. - Integrated Solutions – Close alignment with our drug product, nanomedicines, bioanalytical, and regulatory teams to accelerate timelines and streamline development. With cutting-edge facilities and specialist expertise, Ardena combines scientific rigor with agility. We partner with you to de-risk development, manage complexity, and deliver high-quality APIs on time — providing a seamless pathway from molecule to medicine.