Biomarker Assays
Pharmaron’s bioanalysis team supports assay development, “fit-for-purpose” qualification and full validation adapted to context of use (COU) of biomarkers in a variety of matrices to support discovery, preclinical and clinical drug development.
We provide both GLP and GCP-compliant validation and sample analysis to meet international regulatory standards (FDA, EMEA, NMPA and ICH). Quantitative assays for biomarkers help provide early indicative data on clinical efficacy and/or can be used to assess other druggable targets (e.g. in FIH clinical studies). Quantitative biomarker data are now routinely included in regulatory drug submissions.
- Critical reagent management throughout the assay lifecycle
- Tailored solution in support of study specific monitoring including provision of customized sample collection procedure
- Extensive experience in high-throughput sample analysis using automation
Capabilities
Our Services
Capabilities
- ELISA, MSD-ECL, Flow Cytometry, PCR and Luminex methodology are routinely employed to quantify biomarkers including cytokines
- Multiplex assays (e.g. MSD-ECL, Luminex) are useful for screening in the early stages to evaluate different mechanisms of actions for identification of the most relevant biomarkers as proof-of-concept study
- Hybrid assays, such as LC-MS/MS, together with immunoaffinity (IA-LCMS), can provide superior results compared to large molecule bioanalytical assays in specific circumstances (e.g. improved selectivity, reduced matrix interferences, increased resolution and quantitation of chemically similar analytes)
- Watson-LIMS® data management and sample tracking
