Immunogenicity Assays

Many biotherapeutics have the potential to generate unwanted immune responses in some patients. Unwanted immune responses, like the production of anti-drug antibodies (ADAs), can be caused by a number of factors, including drug structure, patient disease state, and formulation. Immunogenicity assays are critical assessments that screen for potential anti-drug antibodies (ADA) and support product efficacy.

Prolytix supports our partners with comprehensive immunogenicity method development, validation, and testing for preclinical and clinical phases of biotherapeutic development. As your large-molecule CRO partner, we will deliver quality and reliable immunogenicity results to adhere to regulatory requirements and help efficiently advance your biotherapeutic program.

Immunogenicity Bioanalytical Services

Prolytix conducts immune response tests and studies to support your biotherapeutic drug product’s safety and efficacy. All bioanalytical services are conducted from our state-of-the-art GLP, GCLP, CLIA, and GMP analytical laboratories, and our testing facilities maintain an outstanding FDA and client inspection track record. Prolytix’s immunogenicity assay formats vary between different proteins and are likely to depend on the therapeutic protein class. Our immunogenicity services include:

  • Multiple ADA screening assay formats with high reliability and sensitivity for the semi-quantitative or qualitative of potential antibodies
  • Formats to detect antibodies with desired specificities (IgM, IgG subclasses etc.)
  • Direct/Indirect ELISA
  • Bridging ELISA
  • Electrochemiluminescence (ECL)
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