Biomarker Development Services Can Help Accelerate Your Research

Biomarker Assay Development Services

Whether your therapeutic focus is diabetes, infection, neurodegenerative disease, osteoporosis, cancer, or other disease states, our biomarker services can accelerate your drug discovery and development programs. Our BioPharma Services provides consultation and services for proven biomarker assay validation, including “Fit-for-Purpose” strategies coupled with GLP/GCP compliance.

Biomarker Assay Services Provides:

Research and development for both single and multiplex assay kits across diverse therapeutic areas and cell biologies
Access to novel biomarker assays
Custom kit preparation
High quality sample analyses

Biomarker Assay Services Capabilities:

Ligand binding assays (ELISA, RIA, Luminex^® technology, electrochemiluminescence)
Enzymatic assays
Cell-based assays
Absorbance, fluorescence, or luminescence readouts

Conjugation chemistry
Antibody production/purification
Whole cell stimulation assays
Custom kit preparation and validation

Assay Development / Establishment / Transfer
We can:

Develop assays from scratch or adapt any commercially available assay kit
Transfer and optimize non-validated or validated assays to client specifications

Assay Validation:

Validation of analytical methods is crucial in generating data to be used in support of regulatory submissions. Following the most up-to-date industry guidelines, we offer a fully consultative and comprehensive assay validation or cross-validation service. We validate using a fit-for-purpose approach as appropriate for the nature of the assay as well as the stage in drug development.

Industry-Standard Instrumentation and Software:

Molecular Devices SpectraMax^® M5 Microplate Readers
MSD SECTOR^® Imager 2400 and 6000 Reader
Beckman Coulter^® FC500 Flow Cytometer
Titertek^™ Gamma Counter
Luminex^® System
Molecular Devices SoftMax^® Pro GxP