Immunogenicity Assays
Intertek routinely develops and validates immunoassays for the detection of anti-drug antibodies (ADAs) to specific therapeutic macromolecules.
Development and validation of both qualitative and quasi-quantitative immunoassays for the measurement of anti-drug antibodies (ADAs) is a core scientific expertise at Intertek. Each project presents its own unique challenges, so Principal Investigators work very closely with clients to exceed expectations, and to ensure the regulatory requirements for a fully validated assay are met. Several approaches to immunogenicity assessments are offered to ensure that the most sensitive, rugged and reliable techniques are employed.
Assays for Assessment of Immunogenicity
- Development and validation of qualitative assays for total antibody (screen and titer) - includes confirmatory assay (specificity)
- ELISA, ECL, RIA formats (including acid dissociation "AD" and solid phase extraction "SPEAD" and "BEAD")
- Development and validation of cell-based assays for detection of neutralizing antibodies
Integration of PK and Immunogenicity results in animal and human studies
- Toxicokinetics analysis for large molecules
- Clinical pharmacokinetics analysis for Phase I-III clinical trials
Related Services
Request more information to see how Intertek can help your organization with Immunogenicity Assays.