Harmonized ELISpot validation practices are essential for generating reliable cellular immunity data.

As cell therapy, gene therapy, and vaccine development continue to expand, the need for standardized ELISpot assay validation has become increasingly important. This white paper presents consensus recommendations from the Global CRO Council (GCC) to support the development, validation, and implementation of ELISpot assays in regulated bioanalytical environments.

Key topics include:

• Best practices for ELISpot assay development and validation
• Recommendations for validation parameters, including precision, sensitivity, specificity, robustness, and linearity
• Guidance for critical reagent management, quality controls, and assay acceptance criteria
• Strategies to promote harmonization and consistency across regulated ELISpot testing laboratories

Developed through collaboration among leading bioanalytical organizations, these recommendations provide a practical framework for establishing robust, fit-for-purpose ELISpot assays that support cellular immunity testing across preclinical and clinical drug development.