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Applying Biomarkers to Early Clinical Development
Biomarkers are a critical element in achieving better decisions faster in early drug development. When used for statistical comparisons the quality of the bioanalytical assay for a biomarker has a direct impact on the number of participants needed for the study. Celerion develops and validates the right assay for the biomarker, decreasing the timelines and cost of the clinical program.
A successful biomarker program requires scientific expertise, up-to-date regulatory knowledge and operational excellence. Celerion has over 40 years’ experience in performing method development, validation and sample analysis in a regulated environment. Celerion is a partner you can trust to deliver on your biomarker program every time.
We complement our exceptional scientific expertise with state-of-the art technologies in the Celerion laboratories:
- Ligand binding assays such as ELISA, RIA, AlphaLISA, Electrochemiluminescence (ECLA)
- Flow cytometry and cell-based assays
- Multiplex immunoassay platform- Luminex and Meso Scale Discovery
- Enzyme-linked immunospot (ELISpot)
- Liquid chromatography and mass spectrometry (LC_MS/MS)
- Molecular assays and genomics using qPCR
Our wide variety of technology platforms allows us to choose the right technology for your biomarker. Celerion also have extensive experience in applying these technologies in various matrices such as serum, plasma, BAL, saliva, sputum and tissues. Celerion offers three tier biomarker validations based on fit-for-purpose (FFP) approach in a GLP environment that is consistent with all global regulatory guidelines. Celerion also offers biomarker services that in compliance with CLIA regulations.
No matter how complex the assay, our team has the scientific and regulatory expertise to measure your biomarker and to ensure delivery of quality results on time.