Ardena, a specialized Contract Development and Manufacturing Organization (CDMO) and bioanalytical Contract Research Organization (CRO), has officially opened its new state-of-the-art GLP bioanalytical laboratory in Somerset, New Jersey. The facility, which became operational in April 2026, is now supporting client studies, marking a significant expansion of Ardena's scientific capabilities in North America.
Enhancing Bioanalytical Services in the United States
The 2,500+ square foot laboratory is designed to provide biopharmaceutical companies with high-quality bioanalytical services closer to their development programs. This new capability strengthens Ardena's global bioanalytical network and enables closer collaboration with clients throughout North America, facilitating more efficient drug development processes.
Advanced Technological Infrastructure
The operational bioanalytical laboratory includes controlled sample storage, LC-MS/MS systems, and immunochemistry platforms that support quantitative analysis for preclinical and clinical studies. These capabilities allow Ardena to analyze small and large molecules across a wide range of therapeutic modalities, including antibody-drug conjugates and other drug conjugates, as well as biomarker analysis. The facility is supported by a fully integrated electronic Quality Management System (eQMS) and Laboratory Information Management System (LIMS) infrastructure to ensure data integrity and efficient study execution.
Gunnar Flik, Division Head of Bioanalytical Services at Ardena, emphasized the strategic importance of this expansion: "Expanding our scientific capabilities into the United States allows us to work more closely with clients during critical stages of drug development. The new bioanalytical laboratory complements our established teams in Europe and strengthens our capacity to support complex therapeutic modalities in both regions."
Strategic Expansion and Future Plans
The Somerset site, acquired by Ardena in 2025, also includes an FDA-approved facility for advanced drug product manufacturing, supporting clinical development and commercial supply. Combined with Ardena's bioanalytical operations in Europe, this new U.S. capability enables coordinated support for precision medicine development in North America and Europe.
Ardena plans to further expand the site in the coming months with a larger bioanalytical laboratory. This expansion will add additional laboratory space, analytical platforms such as qPCR and flow cytometry, and scientific teams to meet the growing demand for bioanalysis and biomarker services.
About Ardena's Expertise
Ardena is a specialist pharmaceutical CDMO and bioanalytical CRO that enables precision medicines and other complex therapies. Its integrated services support the development of innovative molecules through:
- Advanced drug product development and manufacturing
- Solid-state chemistry
- Bioanalytical services
- CMC regulatory support
The company's bioanalytical expertise includes quantitative and qualitative assays using LC-MS/MS and immunochemistry platforms, supporting small molecules, biologics, peptides, oligonucleotides, and biomarker analysis throughout drug development.
