ELISpot Method Development and Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt and Evolving Trends
Unlike ADA- or NAb-detecting protocols, there is no regulatory guidance currently for how to develop and validate ELISpot methods. The recommendations in the 2019 WRIB White Paper outlining ELISpot assay expectations and performance criteria are therefore meant to harmonize practices and standardize approaches, especially in light of the fact that ELISpot assays require a complex workflow from sample collection to testing. In this webinar, PD Dr. Arno Kromminga and Dr. Juliane Ober-Blöbaum will take a closer look at how to minimize the variability of ELISpot results by controlling the sample collection and handling process as well as by standardizing the peripheral blood mononuclear cells (PBMC) preparations. They will also step through a real-world case study discussing the process of validating an ELISpot assay for the qualitative assessment of cellular immune responses against a virus-based gene therapy.