Immunogenicity

Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins, peptides, monoclonal antibodies (mAbs), PEGylated proteins, multi-domain biotherapeutics, antibody-drug conjugates (ADCs) and cellular therapeutics are likely to be antigenic, which greatly affects the design of safety evaluation programs for biotechnology products.

At Charles River, we have the expertise and resources to develop and validate methods, and perform sample analysis to help you fully study the immunogenicity of your novel compounds in discovery, preclinical and clinical stages.

Immunogenicity of peptide and protein therapeutics and biosimilars is one of the primary concerns held by regulatory agencies worldwide. All therapeutic proteins and peptides can potentially trigger some level of immune response.

Assays

  • ADA screening
  • Confirmatory
  • Titration and isotyping
  • Neutralizing antibody (nAb)

Platforms/Assay Formats

  • ELISA
  • Electrochemiluminescence (ECL) and Meso Scale Discovery (MSD)
  • Flow cytometry
  • SPEAD (solid-phase extraction with acid dissociation)

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