Assess the risk of a cytokine response before patient administration

The Epibase® Cytokine Release Assay (CRA) assesses the risk of a biotherapeutic protein inducing a potentially dangerous cytokine response when administered to patients. The assay assesses the immediate interaction of the biotherapeutic protein itself (or other product-related factors such as formulation components and production contaminants) with the cells of the immune system. Rapid cytokine release is not traditionally associated with an adaptive immune response driven by T or B cell epitopes but more likely to be driven by the mode of action of the biotherapeutic protein or contaminants from the manufacturing process.

Cytokine Release Assay

  • Healthy donor PBMC are incubated with the test biotherapeutic protein for 24-48 hours
  • Supernatant samples are harvested and cytokine/chemokine levels assessed by Luminex®
  • Standard cytokine/chemikone panel includes: G-CSF, GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-13, IL-17A, MCP-1, MIP-1β, TNFα
  • Customized cytokine/chemokine panels may also be used on demand
  • Cytokine release profiles compared to low and high risk biotherapeutic proteins
  • Additional controls may also be included on request (e.g. reference products already on the market)