Table 1.
The ranges of process performance indicators and cell populations from six times manufacturing the BM-MNC isolate.
| Process Performance Indicator | BM-MNCs Relative to Bone Marrow (%) | Acceptance Criteria (%) |
|---|---|---|
| Leukocyte recovery | 13.05 *–22.28 | >15% |
| Erythrocyte depletion | 99.91–100 | >96% |
| Thrombocyte depletion | 95.79–100 | >60% |
| Cell population | BM-MNCs (%) | |
| Viability | 99.50–99.90 | >80% |
| Leukocytes (CD45+) 1 | 63.63–86.87 | - |
| B lymphocytes (CD19+) | 1.08–4.63 | - |
| T lymphocytes (CD3+) | 4.84–9.74 | - |
| CD4+ T lymphocytes | 2.52–4.68 | - |
| CD8+ T lymphocytes | 1.36–3.42 | - |
| Granulocytes (CD16+, CD14−) | 68.23–84.40 | >30% |
| Monocytes (CD14+) | 2.76–10.50 | - |
| CD34+ leukocytes | 1.34–3.59 | >0.1% |
* This cell isolate was not used in experiments. 1 of single viable cells.