Immunogenicity and Neutralizing Antibody

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.

Lab ServicesLaboratory Services by SGSA comprehensive look at SGS’s global lab services (PDF 1,4MB) ...

Multiplex ImmunoassaysBioanalysisMultiplex Immunoassays in BioanalysisThe promises and challenges for implementation (PDF 107KB) ...

• Bioanalytical Services by SGS

  Bioanalysis testing from early to late phase (PDF 92KB)
  Bioanalytical Services (92 KB)
• Life Science Services & Sites Pocket Map

  A quick reference to our global sites and services
  Interactive Pocket Map

Immunogenicity WebinarImmunogenicityA webinar to improve biotech drug development

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All 5 resources

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  Lab Services

  published 02/28/12

  PDF

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  Multiplex Immunoassays

  published 02/29/12

  PDF

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  Bioanalytical Services

  published 02/29/12

  Video

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  Interactive Pocket Map

  published 01/31/12

  Video

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  Immunogenicity Webinar

  published 02/28/12

  Video