Biomarker Centre of Excellence
Biomarker strategy is critical to success
Our personalised biomarker solutions help drive your development to market.
We have extensive experience and a robust range of biomarkers and the skills and expertise to provide you with a right-fit biomarker solution.
Biomarkers are increasingly important in pharmaceutical development and have a wide range of potential clinical utilities. In particular is early phase decision making as indicators of safety and efficacy. We offer biomarker analysis services and have a wealth of experience in detection and quantitation of biomarkers in a wide variety of matrices.
Our biomarker services can be adapted to your specific requirements:
Assay development - Feasibility assessment, establishment and development with a wide variety of analytical methodologies, species and matrices.
Validation - Leading expertise in helping clients develop the most appropriate strategies for validation based on the context of use of the biomarker. We validate using a tiered approach for both in-house and commercial assays to GCP or GLP standards in line with current regulations. All instruments have completed GxP standard computer systems validation.
Quantification - As a measure of drug safety or efficacy, or to prove a new drug’s mechanism of action. We have the capability for small and large molecule analysis, molecular diagnostics and cell based assays.
Capacity - As a pioneer in new analytical approaches and technology, Drug Development Solutions has invested in a broad range of analytical platforms and has one of the largest bioanalytical facilities with more than 200 scientists dedicated to drug development. This allows us to deliver a broad range biomarker solutions including large and complex clinical programmes.
Methods and instrumentation - Our cutting-edge laboratories are well equipped with the latest technology to meet your bioanalytical needs, allowing us to offer a range of assays to meet your pre-clinical to late phase drug development requirements, including:
Plate readers – PerkinElmer Envision readers enabling a broad scope of immunochemical capabilities
Multiplex analysis – Luminex Magpix, MSD™ Sector 600 readers, QuickPlex
High sensitivity assays – fully GxP validated Quanterix HD-X analyser, enabling commercial kit validations and in-house method development using the Quanterix Simoa technology
Automated platforms - Clinical analysers (Immulite 1000/Randox Daytona+) and Gyros xP (Gyrolab™) workstations
Flow Cytometry - Beckman Coulter CytoFLEX, 13-colour, flow cytometers installed in a dedicated cell culture suite
Unique Protein LC-MS service
We have a dedicated team of scientists focused specifically on utilising LC-MS/MS for protein detection
Validation of Nf-L in Human Matrix
We have successfully completed a validation of Neurofilament-Light (Nf-L) in healthy human serum and plasma on one of Europe's first fully validated and compliant HD-X systems.