Bioanalytical Services

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:

• Inflammatory multiplex panels in serum and sputum including IL-1b, IL-1 receptor antagonist (RA), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, Eotaxin, Basic fibroblast growth factor (FGF), Granulocyte-colony stimulating factor (G-CSF), Granulocyte macrophage colony-stimulating factor (GM-CSF), Interferon (IFN)-γ, Interferon gamma[1]induced protein (IP)-10, Monocyte chemoattractant protein (MCP)-1, Macrophage inflammatory protein (MIP)-1α, MIP-1β, Platelet derived growth factor (PDGF)-BB, RANTES, TNF-α and Vascular endothelial growth factor (VEGF).
• Inflammatory cell analysis via sputum, nasal and bronchoalveolar lavage (BALF) differential cell counts (DCCs) and flow cytometric analysis.
• Intracellular Flow cytometric analysis of markers such as phospho-p38 and pSTAT5 in whole blood and sputum.

Development currently underway at the MEU includes inflammatory multiplex analysis and intra-cellular flow cytometric analysis of BALF and Bronchoabsorption samples.