Utilizing Flow Cytometry Within a Quality Control Process for an iPSC-Based Manufacturing Facility

The poster Utilizing Flow Cytometry Within a Quality Control Process for an iPSC-Based Manufacturing Facility presents Axol Bioscience’s approach to integrating flow cytometry into its ISO-compliant QC pipeline for iPSC-derived cell manufacturing.

Key highlights include:

• QC Workflow:
  • Establish pass thresholds
  • Assess cells via flow cytometry
  • Analyze pass/fail status
  • Report within QMS and Certificate of Analysis (CoA)
• Instrumentation:
  • Guava® easyCyte and Attune NxT flow cytometers used for parallel validation
• Pluripotency Assessment:
  • iPSCs tested for SSEA-1 (<10%), OCT3/4, SSEA-4, TRA-1-60, NANOG (>80%)
• Precursor Cell Validation:
  • Monocytes (microglia precursors) tested for CD14, CD16, CD11b, CD206, CD163, SSEA-4
  • Pass thresholds: >80% for lineage markers, <10% for SSEA-4
• Endpoint Cell Characterization:
  • Cardiomyocytes (axo2508) tested for Cardiac Troponin T (>60%)
  • Clear differentiation from iPSCs (1.62% expression)
• Consistency & Troubleshooting:
  • Flow cytometry used to detect immature or aberrant batches
  • Supports axoServices™ for external client QC

This QC framework ensures reproducibility, high-quality cell output, and project success across Axol’s manufacturing pipeline.

Featured Axol Products:

• axoCells™ Cardiomyocytes – ax2508
• axoCells™ Neural Stem Cells – ax0015