All aspects of our bioanalytical services are performed in compliance with GLP and current FDA/EMA guidance.
- Mesoscale Electrochemiluminescence Sector Imager for sensitive PK measurements and Immunogenicity assays.
- BioTek Synergy H4 Multimode Plate Reader using Absorbance, Alpha, Fluorescence or Luminescence reading modes for added flexibility in designing sensitive and customized ELISA assays.
- BioTek EL406 Microplate Washer/Dispenser for increasing sample processing throughput.
- Luminex 200 System for performing multiplexed assays required for both preclinical and clinical studies.
- SQI Diagnostics’ Ig_PLEX™ multiplexing technology for multiplexed biomarker determination.
Our services comprise:
- Assay Development and Validation
- Customizing de novo ELISA Kits in Different Formats (e.g. Competitive, Direct, and Sandwich)
- Development of Immunogenicity Assays for Therapeutic Proteins, Monoclonal Antibodies or Polypeptides (Preclinical & Clinical)
- Method Transfer, Optimization & Development
- Quantitative ELISA Assay Development
- Single or Multiplexed Biomarkers
Quantitative ELISA assays
Our scientists use innovative and cost effective approaches when customizing or developing ligand binding assays for the quantitative determination of your biologic therapeutic products. During assay development, specific attention is given to the selection of the best capture antibody or optimal antibody pair, as well as to the selection of appropriately labeled detection antibodies.
To ensure immunogenicity screening assays have sufficient sensitivity to detect clinically relevant levels of Anti-Drug-Antibodies (ADAs), we compare and apply different assay formats and technology platforms such as:
- Direct binding ELISA using a multimode plate reader.
- Bridging ELISA and electrochemiluminescence (ECL) assays.
- SQI Diagnostics’ Ig_PLEX™ multiplexing technology for ADA screening, isotyping and quantitation.