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CO_Poster CYTO_2025_10May2025_MZ_v5-bg

Poster

CYTO 2025 Poster

Considerations for Global Harmonization and Quality Assessments using spectral flow cytometers

Summary

Flow cytometry is essential for accurate global harmonization and quality assessment, ensuring consistent and reproducible results across multiple sites. Champions Oncology utilizes spectral flow cytometry to achieve robust inter-site comparability, employing a unified workflow with rigorous performance qualification (PQ) and external quality assessments (EQA). This approach minimizes technical variability and ensures that results reflect true biological differences. Given the complexity of global clinical trials, maintaining harmonization between regional sites is critical for reliable data interpretation. Champions Oncology has implemented a high-quality, standardized spectral flow cytometry workflow using the Cytek Northern Lights platform for this purpose.

  • Developed and optimized by Champions Oncology, the standardized workflow integrates daily quality control (QC), monthly performance tracking, and regular PQ assessments. Key markers are monitored using SpectroFlo® beads, while gain stability and detector performance are continuously assessed.

  • The harmonization strategy was validated through participation in the VEQ program (Lombardy Region, Italy), where Champions Oncology demonstrated consistent marker detection and accurate cell counting, aligning with conventional cytometry results from 34 clinical laboratories.

  • Reproducibility results showed consistent marker detection across instruments in both tube and plate modes, with minimal variability in gain values (≤8% CV). These findings confirm that the Champions Oncology workflow supports reliable, reproducible spectral cytometry across global sites.

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