Jeremy Fry: Tools and Technologies for Immunogenicity Risk Management

Developers of biologics recognize the need to understand the immunogenicity of their drug candidates, so that they can manage this risk. Of all the bioanalytical challenges faced in drug design and development, immunogenicity is probably the most important, but also one of the most complex and difficult issues to address. There are many technologies available to manage immunogenicity risk at a preclinical stage - but which should you choose?  I will give an overview of the tools and technologies for immunogenicity risk management, discussing how they can be applied.  These tools include antigen presentation assays to directly characterize HLA-associated peptides using Mass Spectrometry, Dendritic cell - T cell assays to measure responses to fully formulated biologics, physical HLA-peptide Binding Assays, and naïve T cell Proliferation Assays to quantify responses to individual epitopes.  I will also discuss how the potential risk of a cytokine storm first infusion reaction can be identified using whole-blood cytokine release assays.

• #science_technology
• #immunogenicity
• #ex_vivo_assays
• #cytokine_storm
• #prostorm
• #propresent