Zhaojun Yin is a senior scientist at Genentech where he supports the in vitro biological characterization of large molecules and leads the development of immunogenicity assays including NAb and immunogenicity risk ranking assays. He has seven years of experiences in cell-based assay development including NAb assay, potency assay and internalization assays with various platforms.
Biotherapeutics containing endogenous homologs represent one of the fastest growing modality types, and bear a clear immunogenicity risk of generating neutralizing antibodies (NAbs) capable of neutralizing the function(s) of the corresponding endogenous human proteins. This presentation will describe strategic considerations in developing NAb assays for this modality type. Case studies will be discussed to demonstrate technical challenges and solutions to overcome the challenges.