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SGS has been working in the immunoanalysis and immunogenicity testing field for many years.

Our multidisciplinary team of principal scientists and immunoanalysts works with our clients to address their immunoanalytical requirements on a case-by-case basis, offering:

  • Expertise for both pre-clinical and clinical testing
  • Various assay formats (bridging or direct ELISA and RIA)
  • Method transfer or development
  • Method validation following current guidelines and literature
  • Immunogenicity screening assays (peptide/protein drugs and therapeutic monoclonal antibodies):
    • Detection of anti-drug antibody (ADA)
    • Appropriate cut points
  • Immunogenicity confirmatory assays:
    • Demonstration of ADA specificity
    • Use of confirmatory cut points
  • Antibody characterization:
    • Neutralizing ADA assays
    • Cell-based assays 
    • Isotyping
  • Titration testing
  • Cytokine profiling

Flow Cytometry Assay Solutions

SGS also offers the highly versatile technology of flow cytometry analysis to support clinical development. We currently operate a BD FACSCanto II (three lasers, eight colors) equipped with a high-throughput sampler.