Table 1 Quality Control of haMSC-EVs
Parameters | Methods | Specifications |
|---|---|---|
Morphology | TEM | Cup-shape or round vesicles at around 100Â nm |
Size distribution | NTA | Median diameter within 30–160 nm |
Concentration | Â | Report as particles/mL |
CD9 expression | Western blot | Positive |
CD63 expression | Â | Positive |
CD81 expression | Â | Positive |
HSP70 expression | Â | Positive |
CANX expression | Â | Negative |
CD9 positive ratio | NanoFCM |  ≥ 8% |
CD63 positive ratio |  |  ≥ 20% |
CD81 positive ratio |  |  ≥ 15% |
PKH67 positive ratio |  |  ≥ 55% |
Potency assay | ELISA | Inhibition ratio of TNF-α release ≥ 30% |
Endotoxin | ChP 2020 |  < 50 EU/mL |
Sterile | ChP 2020 | Negative |
Mycoplasma | qPCR and ChP 2020 | Negative |
Exogenous virus | ChP 2020 | Negative |