CASE STUDY: Method Transfer and Optimization of a Flow Cytometry Method Following Best Practice in a Regulated Environment
Eurofins Bioanalytical Services developed a Fit-for-Purpose validation assay for analyzing frozen PBMC samples in a clinical study assessing an intradermal peptide vaccine with checkpoint inhibitors in advanced solid tumor patients. They identified and quantified activated WT1-restricted CD8+ cytotoxic T lymphocytes using immuno-phenotyping and MHC tetramer reagents, and generated CTLs as process QCs for method qualification and sample analysis.
