Total Antibody Assays for AAV-Based Gene Therapies – To Bridge or Not to Bridge
Assessing humoral immunogenicity is an interesting challenge for adeno-associated virus (AAV)-based gene therapies. While most people are concerned about how to deal with pre-existing antibodies and their impact on cutpoints — such as using total antibody or neutralizing antibodies for inclusion/exclusion, including/excluding based on these results, and a number of other concerns — often times just coming up with the right assay format for measuring these antibodies is overlooked. The goal of this webinar is to provide case studies for the two typically used assay formats for measuring total antibodies (direct and bridging) and discuss the challenges and rationales for using each of them in the AAV immunogenicity space. The case studies will be followed by a panel discussion with an expert scientific team to take questions and discuss other possibilities for assay format selection.