Human administration of recombinant proteins or biological substances can elicit an immune response leading to the production of antibodies, which in some cases may neutralize their activity. This makes the assessment of immunogenicity an essential component of biologic safety evaluation. While bioavailability, pharmacokinetics and pharmacodynamics (PK/PD) can be effected leading to impaired efficacy, such immunogenic responses can also induce allergic reactions where in some cases severe autoimmune reactions may occur.
We provide immunogenicity services by developing and applying methods commonly required in safety and efficacy studies, such as PK/PD, bridging immunogenicity, drug tolerance and neutralization assays. We currently offer screening assays, antibody characterization and quasi-quantitative titers that describe anti-drug-antibody (ADA) immune responses. These services are available on multiple platforms including the Mesoscale Discovery (MSD) Imager (ECL), Alpha-Lisa bead-based assays with luminescence or fluorescence detection, ELISA and our newest immunogenicity platform the, SQI Diagnostics’ SQiDlite™ multiplexing system.
For more information regarding our Immunogenicity services and our newest platform please click here.