eChalk Talk: Bioanalytical Strategy for Immunogenicity Assessment of ATMPs

Due to the complexity of ATMPs, it is critical to evaluate the potential immune responses to these novel drugs as it can impact both safety and efficacy.  Scientific Officer Lynn Kamen, PhD, and Scientist I, Emaan Madany, PhD, review the different platforms that are used to evaluate the immunogenicity of ATMPs including ligand binding assays, flow cytometry, and ELISpot, and discuss the key considerations for assay development and validation.