President/CEO ZellNet Consulting, Inc. Fort Lee, New Jersey
For more than four decades, ELISpot has outlasted waves of newer and more complex technologies — because it remains a truly fit for purpose assay for sensitive, single cell immune response measurement. Extensive harmonization efforts and clear validation guidelines have turned ELISpot into a ready to use, highly reliable platform for clinical studies. The evolution to FluoroSpot now enables robust polyfunctional analyses, supported by advanced reader systems, intelligent data processing algorithms, and increasing automation across the workflow. Together, these developments make ELISpot and FluoroSpot indispensable tools that consistently deliver reproducible data aligned with study decisions and endpoints. Attendees will gain practical guidance on designing, evaluating, and troubleshooting these assays to ensure data that withstand scientific and regulatory scrutiny.
Learning Objectives:
define the fit for purpose characteristics of ELISpot and FluoroSpot assays and their relevance to bioanalytical decision making in drug development.
describe current harmonization and validation frameworks that support assay robustness, reproducibility, and regulatory defensibility.
evaluate the impact of advanced reader technologies, analytical algorithms, and workflow automation on assay performance and data integrity
identify common sources of variability in ELISpot/FluoroSpot workflows and apply practical strategies to mitigate risk
apply fit for purpose principles to real study scenarios to ensure immune monitoring data appropriately support program decisions and regulatory expectations
