BioMarker 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. Millipore BioPharma Services provides consultation and services for proven biomarker assay validation, including “Fit-for-Purpose” strategies coupled with GLP/GCP compliance.

The following services are jointly available across our two North American and European sites.

Millipore is the leading provider of:

• 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.

Technology:
Millipore uses industry-standard instrumentation and software to facilitate assay transfer and validation, including:

• 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
• MSD^® DISCOVERY WORKBENCH^® Software
• Beckman Coulter MxP and CxP
• StatLIA^® Data Reduction Software
• Watson^™ LIMS
• Validated Excel^® worksheets for data analysis
• Complete electronic documentation management system

For more information:

• Immunoassay Services