Conducting immunogenicity risk assessment as part of a developability package and lead candidate selection before clinical trials de-risks the development of biologics and supports a strong IND application. These assays are evolving to become more data rich, and in this webinar, we summarize the current field and future directions. As such, we describe the development of a sensitive flow cytometry- based assay which assesses T cell proliferation using an EdU readout, multiplexed with customizable activation markers and assessment of cytokine levels to gain more insight into immunogenicity risk. We also show that immunogenicity risk assessment can be ‘flipped’ to aid vaccine development with a case study on MHC class I assays to facilitate epitope identification.
Key Takeaways:
- Immunogenicity testing as part of developability in the early stages of drug development helps to de-risk progress at later stages.
- Assays have evolved to include multi-parametric readouts, (proliferation, activation markers, cytokine levels) informing better decision making.
- Novel Episcreen® assays can be customized to interrogate particular cell populations and/or mode of actions.
- Class I responses can be determined by in silico, MAPPs and functional assays to aid vaccine design.
Learning Objectives:
- How immogenicity testing as part of developability can help to de-risk drug development progress
- The evolution of assays and how they can inform better decision making
- How immunogenicity risk assessment can aid vaccine development
