The CDMO Ardena has announced the opening of its new state-of-the-art GLP bioanalytical laboratory in Somerset, New Jersey.
The lab, which comes in at more than 2500 sq ft, should boost Ardena's capabilities in North America. It will provide biopharma companies with access to high-quality bioanalytical services closer to their development programmes, strengthening Ardena's global bioanalytical network and enabling closer collaboration with clients.
The new bioanalytical laboratory features controlled sample storage, LC-MS/MS systems and immunochemistry platforms for quantitative analysis in preclinical and clinical studies.
These capabilities enable the analysis of small and large molecules across various therapeutic modalities, supporting 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."
Acquired by Ardena last year, the Somerset site includes an FDA-approved facility for advanced drug product manufacturing supporting clinical development and commercial supply.
Combined with the firm's bioanalytical operations in Europe, the new US capability enables coordinated support for precision medicine development in North America and Europe.
Ardena added in its release that it plans to further expand the site in the coming months by adding a larger bioanalytical laboratory, additional laboratory space and analytical platforms, including qPCR and flow cytometry, as well as by adding scientific teams to support growing demand for bioanalysis and biomarker services.