We have a dedicated bioanalytical team with over 10 years’ experience in all aspects of pharmacodynamic biomarker assay development and validation in a variety of complex matrices.
We have 3 bioanalytical laboratories dedicated to serum, sputum and BALF differential cell counts, plate based immunoassays (ELISA & Luminex), immunophenotypic and intracellular flow cytometry.
We are able to provide complete management of biomarker analysis within a clinical study, as a single site or acting in a central laboratory capacity, from study design including the generation of pre-clinical data to inform on biomarker suitability through to basic descriptive statistical analysis of the biomarker data generated.
In addition to assays currently validated at the MEU, our access to a variety of biological matrices allows us to offer a fully bespoke assay development and validation service dependent on specific study requirements.
Our experience in assay validation has led to the development of a robust fit-for-purpose assay validation approach, as published in the paper “Validation of Sputum Biomarker Immunoassays and Cytokine Expression Profiles in COPD” and presented at international respiratory conferences.
Currently validated assays include:
Development currently underway at the MEU includes inflammatory multiplex analysis and intra-cellular flow cytometric analysis of BALF and Bronchoabsorption samples.