Executive Director Eli Lilly and Company, Inc. Indianapolis, Indiana, United States
One of the challenges for the development and comparison of preclinical in vitro immunogenicity risk assays is the lack of availability of standard positive and negative control therapeutic proteins for use in assay qualification and as benchmarks for comparison of relative immunogenicity. Here we will discuss the cross-industry work led by HESI and AAPS to develop common reference biologics for immunogenicity risk assessment, a critical first step toward assay harmonization.
