Ardena, a specialist CDMO and bioanalytical CRO enabling precision medicines and other complex therapies, announces that its new state-of –the-art GLP bioanalytical laboratory in Somerset, New Jersey, is now operational and supporting client studies.

The 2,500+ sqft laboratory expands Ardena’s scientific capabilities in North America and provides biopharma companies with access to high-quality bioanalytical services closer to their development programs. The new capability strengthens Ardena’s global bioanalytical network and enables closer collaboration with clients throughout North America.

The operational bioanalytical laboratory includes controlled sample storage, LC-MS/MS systems, and immunochemistry platforms supporting quantitative analysis for preclinical and clinical studies. These capabilities enable Ardena to analyze small and large molecules across a wide range of therapeutic modalities and support global clinical trials.

“Expanding our scientific capabilities into the United States allows us to work more closely with clients during critical stages of drug development,” said Gunnar Flik, Division Head of Bioanalytical Services at Ardena. “The new bioanalytical laboratory complements our established teams in Europe and strengthens our capacity to support complex therapeutic modalities, including antibody-drug conjugates and other drug conjugates, as well as biomarker analysis, in both regions. We are also continuing to invest in additional capabilities, including PCR and flow cytometry platforms, supported by a fully integrated eQMS and LIMS infrastructure to ensure data integrity and efficient study execution as we scale.”

The Somerset site, acquired by Ardena in 2025, includes an FDA-approved facility for advanced drug product manufacturing supporting clinical development and commercial supply. Combined with Ardena’s bioanalytical operations in Europe, the new US 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, adding additional laboratory space, analytical platforms including qPCR and flow cytometry, and scientific teams to support growing demand for bioanalysis and biomarker services.