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Our Services >> Immunoanalytics >> Immunogenicity Testing Services

Immunogenicity Testing Services

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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.