Optimisation of In Vitro T Cell Assays to Assess Preclinical Immunogenicity Risk to Biotherapeutics

摘要

Pre-clinical immunogenicity risk is being increasingly studied in the process of drug design to assess the impact of CD4+ T cell epitopes as well as the effects of the biophysical and biochemical profiles of molecules such as aggregates, post-translational modifications and host cell proteins. In order to characterise the potential repertoire of the response to CD4+ T cells, evaluation requires the inclusion of HLA typed donors to account for HLA variation in the population of interest.