Discover how strategic assay optimization improved the consistency and reproducibility of a complex flow cytometry assay to support a multi-site Phase 1b/2 immuno-oncology clinical trial.

Complex flow cytometry assays require robust methods, reliable quality controls, and consistent performance throughout clinical testing. This case study highlights how Eurofins Viracor BioPharma transferred, optimized, and validated a 7-color flow cytometry assay designed to identify, characterize, and quantify WT1-specific CD8+ cytotoxic T lymphocytes (CTLs) from frozen PBMC samples. The optimized approach supported a multi-site Phase 1b/2 study evaluating peptide vaccine therapies in combination with checkpoint inhibitors in adults with advanced solid tumors.

Key highlights include:

• Transfer and optimization of a complex 7-color flow cytometry assay for clinical trial application
• Development of robust WT1-specific CTL quality control materials for ongoing assay monitoring
• Improved assay consistency and reproducibility through strategic method optimization
• Optimized multi-parameter analysis templates and instrument-specific workflows
• Close scientific collaboration to refine culture conditions, reagent selection, and cell maturation workflows
• Achievement of stringent client performance requirements and project timelines
• Delivery of a reliable testing solution to support critical immuno-oncology development decisions

This case study demonstrates how flow cytometry expertise, customized assay development, and scientific collaboration can help overcome complex analytical challenges, improve data confidence, and support clinical development programs.