Bioanalytical Method Development

  • Assay Development Services

  • Your Expert in Customized Bioanalytical Method Development

    METHOD DEVELOPMENT

    During more than ten years, IBA’s Method Development Service has provided assay solutions for the pharmaceutical, diagnostic, and biotechnology industries. Using our proprietary approach to assay method development ensures an optimized bioanalytical method that is tailored to meet your specific needs and is delivered both on-time and on-budget.

    Available Assay Development Platforms:

    • Radioimmunoassay (RIA)
    • Fluorescent Detection
    • Chemiluminescent Dectection
    • Enzymatic (colorimetric) Detection
    • Luminex® 100™
    • Bio-Rad® Bio-Plex™
    • MSD® SECTOR™
    • Cell-based Assay
    ELISA / EIA
    • Perkin Elmer® Envision™

    IBA’s Method Development Service delivers an immunobased method using antibodies that you provide, commercially available antibodies, or for a more custom approach you can enlist IBA’s Antibody Production Services. With the antibodies and reagents in place, IBA will provide results in 4-6 weeks under typical circumstances. Cell-based Assay projects are typically delivered in 8-10 weeks.

    As is appropriate, each assay is validated identifying the following metrics:

    Precision
    Lower Limit of Quantitation (LLQ)
    Upper Limit of Quantitation (ULQ)
    Dynamic Range
    Linearity
    Parallelism
    Spike and Recovery (accuracy)
    Minimum Detectable Concentration (MDC)
    Specificity

    In addition to a quality method and validation in a timely fashion IBA can customize a package to include:

    Analysis with chemical or biologically derived samples
    Analysis with universal standards where available (WHO/NBISC)
    A formal method development report
    Detailed assay protocol
    Assay method education and training to streamline method transition into your lab.
    Reagent/Sample stability
    Endogenous/Exogenous interferants
    Establish normal ranges
    Cross reactivity
    Correlation with a reference method

    Expertise:
    IBA has greater than ten years of experience in creating unique and novel approaches to immunobased and cell-based methods. Supported platforms and approaches include:

    Multiplexed Technologies
    -Meso-Scale Discovery® Sector Imager®
    -Bio-Rad ®Bio-Plex®
    -Luminex® 100

    Singleplexed Technologies
    -Radioimmunoassay (RIA)
    -Enzyme Immunoassay (EIA)
    -Perkin Elmer® Envision™

    Cell-based Assay
    -Median Inhibition Concentration

    Determination (IC50)
    -Kinase Profiling Assays
    -Phosphoprotein Analysis
    -Biomarker Analysis
    -Receptor Binding
    -Cell Signaling
    -Cytotoxicity
    -Cytokine and Chemokine Production

    To contact an IBA representative call (203) 315-5972 or e-mail: info@iba-analytics.com