Explore the principles of ELISpot assay specificity and the strategies used to generate reliable, meaningful cellular immune response data.

This eBook examines the factors that influence ELISpot assay specificity, including donor variability, antigen selection, and T-cell specificity. It also features expert guidance, industry white papers, and a real-world case study highlighting assay development, validation, and transfer for vaccine clinical trials, providing practical recommendations for robust immunogenicity testing.

Key topics include:

• Understanding donor, antigen, and T-cell specificity in ELISpot assays
• Recommendations for ELISpot assay development, validation, and harmonization from the Global CRO Council (GCC)
• Best practices for assay validation, quality controls, and critical reagent management
• A real-world case study demonstrating ELISpot assay development, validation, optimization, and transfer for a vaccine clinical trial

As cellular therapies, gene therapies, and vaccines continue to advance, robust ELISpot assays are essential for accurately measuring immune responses. Discover the scientific principles, validation strategies, and practical guidance that support reliable ELISpot testing throughout clinical development.