Pharmacodynamic (PD) & Biomarker Immunoassays
Biomarker assays are becoming increasingly important in clinical development. These assays can be used to aid the selection of a lead candidate and to understand the mechanism of action of a drug. The use of biomarker assays can provide an early indication of drug efficacy, helping to reduce attrition rates, optimize clinical development programs, and provide critical information around safety parameters. To support regulatory submissions, the data from these assays must be robust and fit for purpose.
Example Projects
Biomarker assay panel supports cancer trial at NHS hospital
ELISAs for a panel of potential cancer markers and their phosphorylated forms were developed by Fleet, requiring careful attention to specificity. The resulting assays have been used to support a clinical trial conducted by an NHS hospital.
Fleet provide long-term reagent supply to a Dutch company for their cardiac biomarker ELISA
On behalf of a Dutch company, Fleet optimised and developed an ELISA for a novel cardiac biomarker. As part of this development program, a panel of antibodies against the marker were conjugated and screened for assay performance. Once the optimum reagents had been determined and the assay developed, Fleet continued to provide long-term support with the supply of additional critical reagent batches.