Anti-drug antibodies (ADA) and Neutralizing Antibody (NAb), especially the latter as functional mechanistic and predictive biomarkers for biologics, comprising large molecules, vaccines, and Gene and Cell therapies (GCT), become indispensable for precision medicine. For ADA, we show that the extensively applied bridging assay is not suitable for aggregated drugs; the widely employed mesoscale discovery (MSD) format should be replaced by spectraMax ELISA assay when sulfo-tag labeled drug is unstable. For complex gene or virus drug NAb examination, a carefully designed reporter assay has a better performance. As the PK profile is also critical, especially for drug removal, automation should be considered to reduce the variability for sophisticated assays. Taken together, our extensive practices and services reveal that a deeper understanding of biologics is the fundamental prerequisite to accomplishing method development and validation of ADA and NAb assay with a set of formats aligned with priorities.
Learning Objectives:
Distinct formats of cell-based and non-cell-based immunogenicity assay for complex biologics
Upon completion, participants will be able to understand distinct formats of ADA assays.
Upon completion, participants will be able to understand non-cell based NAb assays.
Upon completion, participants will be able to understand cell-based NAb assays.