Predict Innate Immune Responses

The Innate Immune Response Assay is intended to assess the innate immunogenicity that may result from formulated and packaged drug products using fresh PBMC samples derived from healthy human blood donors within a 24-hour timeframe to closely mimic a natural, human innate immune response.

Samples are cultured and stimulated with a panel of innate immune pattern recognition receptor (PRR) agonists as positive controls and compared to the test articles. Culture supernatants are assessed for the expression patterns of 9 cytokines indicative of innate immune response activation using a Cytokine Bead Array assay running through flow cytometry. 

The Innate Immune Response Assay is useful for comparing the innate immunogenicity of the generic peptide and reference listed drug (RLD) products. The assay could also be adapted to assess cytokine storms in response to biologic products.