Table 1.
BMSC lot release criteria
| Test | Method | Criteria |
|---|---|---|
| CD73 | Flow cytometry | ≥80% reactive cells |
| CD90 | Flow cytometry | ≥80% reactive cells |
| CD105 | Flow cytometry | ≥80% reactive cells |
| CD146 | Flow cytometry | ≥60% reactive cells |
| CD34 | Flow cytometry | ≤5% reactive cells |
| CD45 | Flow cytometry | ≤5% reactive cells |
| CD14 | Flow cytometry | ≤5% reactive cells |
| CD11b | Flow cytometry | ≤5% reactive cells |
| Viability | Trypan blue | ≥70% |
| Sterility | Bactec Plus, aerobic and anaerobic | No growth after 14 days |
| Mycoplasma | PCR | Negative |
| Endotoxin | Limulus Amebocyte Lysate (LAL) | < 5.0 EU/mL |