Total Antibody Assays for AAV-Based Gene Therapies – To Bridge or Not to Bridge

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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.

About the Speakers

Jim McNally, Ph.D. (Moderator) is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance.

Jay Stringer, Ph.D. has more than 10 years’ combined experience working with numerous immunoassay formats in academic, clinical, and BioAgilytix labs. At BioAgilytix, Jay currently manages a team of scientists and analysts developing, qualifying, and validating assays to support sample testing for clients. He has supported multiple clients in different species for AAV ADA testing utilizing a simple bridging approach on the MSD platform.

Luke Armstrong, Ph.D. has over a decade of experience in reagent product development and contract research in cell-based assays, pharmacology, molecular cloning, protein expression, and immunoassays. In his role at BioAgilytix, Luke manages a research and development and operations team providing quality services in cell-based assays for detection of neutralizing antibodies to large molecule biologic drugs. Luke earned his Ph.D. in Biochemistry and Molecular Biology from the University of California, Davis, and was a postdoctoral fellow in the Department of Biochemistry at the University of Washington.

Todd Lester is a seasoned biotechnology and pharmaceutical project management professional. In his role at BioAgilytix, he oversees and leads all technical aspects of complex bioanalytical studies, including design, interpretation, analysis, documentation, and reporting of results, investigations, and deviations.

Xiaoxi Yang, Ph.D. has 10+ years of experience in assay/device development research in the Pharmaceutical/Diagnostics fields. In her role at BioAgilytix, Xiaoxi manages an operations team to develop and validate ligand binding assays to support the trials for large molecule biologic drugs. She led and executed several anti-drug antibody (ADA) assays to support adeno-associated virus (AAV)-based gene therapy programs with varying formats.

Marianne Scheel Fjording, MsC, PhD. has an extensive background in large molecule bioanalytical assay set-up and assay validation with 25+ years of experience working in the pharmaceutical and biotechnology industry. In her role as Scientific Officer, Executive Director, she provides scientific and regulatory support to clients and the operational teams at BioAgilytix as well as bioanalytical strategies to clients.