Specifically engineered to meet your needs from pre-clinical to small-scale commercial manufacturing, we have specialist facilities and expertise for handling highly potent compounds and controlled substances.
Advancements in drug research, especially in oncology, inflammatory diseases, and antiviral compounds, have driven the development of new therapies with potent compounds and controlled substances.
Our specialized approach guarantees a seamless transition into clinical programs, backed by dedicated facilities and expert teams, covering the spectrum from pre-clinical exploration to small-scale commercial manufacturing.
Our platform seamlessly integrates the development of high-potency substances, the formulation of drug products, and advanced Solid State Research conducted in-house. This comprehensive approach ensures a streamlined process from inception to production, supported by state-of-the-art facilities and specialized centers.
In early drug development, we adopt a risk-based approach. This includes reviewing compound properties, conducting risk assessments, designing processes, and implementing mitigation strategies before manufacturing. We refine our approach with emerging data, focusing on long-term success through QbD principles for scalability, transferability, and manufacturing optimization.
Located within our facilities in Oss, the Netherlands, are dedicated High Potent Laboratories and manufacturing units specializing in Highly Potent Active Pharmaceutical Ingredients (HPAPIs) and Solid State Research (SSR). Equipped to handle HPAPIs up to OEB5 (OEL 0.1-1 microgram/m3), our SSR laboratories hold permits for controlled substance experimentation.
Our API manufacturing facility, established in 2001, is capable of handling highly potent compounds, with design elements such as segregated workflows and pressure cascading systems to prevent cross-contamination and ensure contained processing.
Ardena’s commitment to excellence extends to drug product formulation and analytical development, with dedicated suites tailored for HPAPI handling.
Our laboratories feature 100% air renewal systems and stringent safety protocols, safeguarding both operators and potent products.
Operating within a specialized GMP manufacturing plant meeting EU-GMP class C standards, we uphold the highest quality standards, enabling work with substances in categories 1 to 4 (up to OEL of 0.1 µg/m3).
Ardena’s expertise spans the development and manufacturing of drug products containing controlled substances, aligned with Schedule 2 through 5 categories.
Our facilities, processes, and regulatory proficiency ensure compliance with stringent storage, testing, and handling requirements.
Within our SSR facilities in Oss, we possess permits for list I and II controlled substance experimentation under the Dutch Opium Law, ensuring comprehensive support and regulatory adherence.
Our expert team members share deep, scientific understanding and insights into manufacturing highly potent and controlled substances.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Helping you turn your compounds that show promise into GMP-grade drug substances.
We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.
We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.