Assays for immunogenicity prediction

New biotherapeutic drugs that elicit complex immune responses are revolutionizing the field of immuno-oncology (IO). Unwanted immune responses can result in severe adverse effects, therefore their early detection is vital. 

Cellular assays for immunogenicity prediction offer several benefits: 

  • Immune response can be monitored directly from blood, PBMCs, or isolated cell subsets;
  • Human primary cells represent a more reliable physiology;
  • No animal testing required; afford the possibility of testing different HLA types and selected test populations;
  • Minimize the risk of overprediction and so on.

However, several challenges need to be taken into account when setting up a cell-based assay for immunogenicity prediction, such as most of the PBMC and target cell isolation techniques are Ficoll®-based. This requires lots of hands-on-time and toxic reagents. Another challenge is that the culturing of primary cells often leads to unreproducible results due to the bias introduced by unstandardized culture media and cytokine reagents. A final challenge is the detection of rare responses is often jeopardized by the lack of highly-sensitive and robust analytic instruments. 

Percentage of patient anti-drug-antibody responses and DC:T assay

In this study, a DC:T assay was performed to predict the immunogenicity potential of different therapeutic antibody candidates. T cell proliferation data from the DC:T assay was compared with percentage of patient developing anti-drug-antibody response under clinical trial. Linear correlation between these data-sets indicated sensitivity of the in vitro assay for immunogenicity prediction. 

Immunogenicity testing – drug development

Watch the webinar to learn about immunogenicity testing at the early phase of drug development. Find out how it can play a crucial role in avoiding possible clinical consequences of unwanted immune responses.

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