Automated Flow Cytometry Assay Facilitates Monitoring of T Cell Health for Cell Therapy Manufacturing

Summary

• The automated T Cell Health Assay (Non-Lyse) is in development to support standardized assessment of major T cell subsets and their health state (viable, apoptotic, late apoptotic/dead) in samples critical for cell therapy development and manufacturing, reducing operator-dependent error and subjective analysis.
• Viability measurements obtained using the T Cell Health Assay (Non-Lyse) correlate with a cell counting method, supporting comparability to established methods.
• Defined mixtures of EtOH-treated and untreated PBMCs demonstrated the assay’s ability to measure shifts in cell health state, while preserving accurate identification of CD3+, CD4+, and CD8+ T cell subsets.
• Measurements were reproducible across multiple instruments and two PBMC donors, with low instrument to instrument variability for both phenotyping and T cell health metrics.
• The standardized reagents, minimal hands-on workflow, automated analysis, and exportable reports enable rapid decision-making at the point of use supporting real-time manufacturing control with offline analysis and troubleshooting as needed.

The Accellix Platform enables automated, standardized characterization of cell materials at the point of need, minimizing variability and subjective data analysis, and providing rapid cell phenotyping for cell therapy development and manufacturing.