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Validation of a potency assay for CD34 + cell based therapy
Christine Vignon1, Arthur Cormier1, Aurélien Goubaud1
1CellProthera, 12 rue du Parc, Mulhouse, 68100, France.
Scientific Reports
|August 12, 2025
Summary
A new assay quantifies vascular endothelium growth factor (VEGF) secreted by ProtheraCytes, ensuring cell therapy product quality. This validated potency assay enables timely batch release for clinical use.
Area of Science:
- Cell therapy
- Regenerative medicine
- Assay development
Background:
- ProtheraCytes, expanded autologous CD34+ cells, promote myocardial regeneration.
- Revascularization is achieved through angiogenesis driven by vascular endothelium growth factor (VEGF) secretion.
Purpose of the Study:
- To develop and validate a potency assay for ProtheraCytes based on VEGF quantification.
- To ensure timely batch release of ProtheraCytes for clinical application.
Main Methods:
- Development of a potency assay using an automated ELISA system (ELLA) to quantify secreted VEGF.
- Validation of the assay according to international guidelines for cell therapy products.
- Assessment of linearity, precision, accuracy, and specificity.
Main Results:
- The assay demonstrated a linear response (R² = 0.9972) within the range of 20 pg/mL - 2800 pg/mL.
- Precision was confirmed with coefficients of variation ≤10% (repeatability) and ≤20% (intermediate precision).
- Accuracy was established with mean recoveries between 85% and 105%, and specificity was confirmed by low basal VEGF levels.
Conclusions:
- The validated VEGF potency assay is reliable, quantitative, and suitable for the timely release of ProtheraCytes.
- The assay supports quality control for cell therapy products.
- Assessment of 38 clinical batches confirmed the assay's suitability.
