Biomarker Services
Biomarkers are playing an increasingly important role in clinical studies where they can provide essential efficacy, safety, and pathology data around the drug and indication being investigated. While early-phase first-in-human studies are typically focused on safety in healthy subjects, with pharmacokinetics as the main secondary endpoint, biomarker-based studies can offer crucial insights from the outset.
Biomarkers
A Biomarker can be described as an indicator of biological function or activity or a defined characteristic that is measured as an indicator of normal biological responses, pathogenic processes or a biological response to an exposure. Biomarkers might be therefore be soluble proteins, cell populations, molecular biomarkers (DNA or RNA) or a biological process (e.g., blood pressure).
At Agilex, we use a context-of-use (COU) framework for Biomarker assays. The COU is a concise description of the biomarker’s specified use in the study. Each qualification or validation effort for a biomarker should identify a single COU, to understand the purpose of the biomarker to guide assay selection at the outset and to provide an understanding of the expected data (expected fold change of dosed individuals compared with pre-dose/basal or expected pharmacodynamic changes elicited by the therapeutic).
Scientific Expertise
The Agilex Scientific team have considerable experience in setting up off the shelf or custom biomarker assays to support a study. We use LC-MS/MS, LBA (single or multiplex assay), Gyros to measure soluble biomarkers in a range of matrices (serum, plasma, urine, CSF, feces, saliva, tissues) in healthy and diseased matrix. We use Flow cytometry and ELISpot to enumerate biomarkers from single cells and PCR to detect molecular biomarkers (DNA, RNA).
Biomarker Services
Assays supported
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Over 28 years of experience in developing and validating robust compliant immunoassay, immunogenicity, and cell-based assays to support nonclinical and clinical programs.
Experts in overcoming bioanalytical challenges from new chemical and biological entities.
Agilex offers a wide range of kit productions and logistics services to explore
Supporting non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facilities.
Determine key insights into a therapeutic’s efficacy, safety profile, and mechanism of action.
