Table 1 BMSC lot release criteria
From: The establishment of a bank of stored clinical bone marrow stromal cell products
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 |