Immunogenicity Testing Services
Eurofins BioPharma Product Testing Munich applies a tiered immunogenicity testing methodology accompanied with statistical data analysis and support following GLP/GCP standards.
Our Expertise and Experience in Immunogenicity Testing
Screening assay
- Identification of positive samples based on cut-point
- Direct or bridging format (e.g. ELISA,MSD®-ECL, DELFIA)
Confirmatory assay
- Competitive inhibition test to eliminate false positive samples
Neutralization assay
- Investigation of the functionality of positive samples
- Cell-based assay, ligand binding assay
- Based on potency Assay
Characterization assays
- Isotype
Biosimilar Assay Development & Testing
Additionally, Eurofins BioPharma Product Testing Munich GmbH offers customized immunogenicity assays for the comparability testing of both the biosimilar drug and its clinical Performance.
