Bioanalytical and Bioassay Services for Biologics and Biomarkers

XBL offers state-of-the-art instrumentation combined with scientific expertise to support biologic drug development and biomarker/cell-based assay development. Services include ECL-based ELISA immunoassay development, validation and sample analysis and cell-based assay development, featuring in-vitro, pre-clinical toxicity profiling. Cell signaling pathway analysis is also available.

List of Validated Methods for Protein and Biochemical Biomarkers at XBL (PDF)

Immunoassays:
New state-of-the-art SECTOR Imager 6000 from Meso Scale Discovery (MSD) provides premiere electrochemiluminescent (ECL) technology for immunoassays.

• Provides increased sensitivity, wide dynamic range, and improved drug tolerance in immunogenicity assays, fewer matrix effects and more overall flexibility over traditional ELISA methods.
• Multiplexing capability allows quantitative measurement of multiple analytes or protein biomarkers in a single test sample, significantly reducing turn-around time for sample analysis
• Study conduct at exploratory, non-GLP, or fully GLP compliant levels

Services Available:

• Biotherapeutic macromolecule PK & PD
• ELISA-based applications
• Immunogenicity assays
• Multiplex assays
• Method development & validation
• Biomarker services: efficacy & safety assessment

Cell-Based Assays:
New laboratory for conducting various cell-based assays to support discovery, pre-clinical and clinical studies.

Services Available:

• Biological activity of small molecule compounds & macromolecules
• Pre-clinical toxicity profiling: cell proliferation and cell death
• Antibody neutralization testing
• Cell signaling/phosphorylation analyses