Scientist/Bioanalytical Project Manager BioAgilytix, United States
Assessment of humoral immunogenicity for adeno-associated virus (AAV)-based gene therapies is a required component of clinical assays. The typical assay format used for anti-AAV antibody assays has been the direct binding format, due to challenges encountered in development of the bridging format. This presentation will detail a case study for the successful development and validation of a bridging assay for an anti-AAV9 total antibody, including challenges, rationale, and considerations for developing this type of assay format. The case study will also highlight the impact of pre-existing antibodies on cut-point determination and utilizing the assay for inclusion/exclusion in clinical studies.
Learning Objectives:
Upon completion, participants will be able to understand considerations for developing and validating anti-AAV bridging assays.
Upon completion, participants will discuss a case study for the successful development and validation of a bridging assay for an anti-AAV9 total antibody.
Upon completion, participants will be undersatnd the impact of pre-existing antibodies on cut-point determination and utilizing the assay for inclusion/exclusion in clinical studies.
