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
We have extensive experience with a range of biomarkers, including those linked to:
- Target engagement
- Coagulation cascade
- GI disorders
- Inflammatory diseases
- Neurological disorders
- Respiratory diseases
- Renal disease/damage
- Stress management
Download fact sheet
Biomarkers Assay List
We have extensive experience in detection and quantitation of biomarkers in a wide variety of matrices.
Biomarker Centre of Excellence
At our Cambridge (Fordham) facility, our expert biomarker teams support non-clinical and clinical biomarker method development, validation and sample analysis. At Drug Development Solutions, we believe that the key to success is initiating early discussions to clarify the context of use for the data and tailor the subsequent validation on a case-by-case basis.
Quanterix HD-X. Validation for GxP sample analysis
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.