Table 2 Quality control of 12 DC vaccines
Patient no. | 01 | 02 | 03 | 04 | 05 | 06 | 07 | 08 | 09 | 10 | 11 | 12 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Sterility | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Mycoplasma | ||||||||||||
I (PCR) | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
II (Direct culture) | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Endotoxin (<10 EU ml−1) | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Viability (%)a | 83.1 | 85.7 | 75.4 | 77.2 | 86.8 | 80.8 | 88.2 | 88.2 | 86.1 | 76.5 | 89.8 | 78.6 |
Phenotype identification | ||||||||||||
Size and granularity (%)b | 85.1 | 90.9 | 93.6 | 93.8 | 96.4 | 93.7 | 97.8 | 96.6 | 84.4 | 89.1 | 91.5 | 92.2 |
 Cell surface phenotype (%)c |  |  |  |  |  |  |  |  |  |  |  |  |
 HLA-DR | 96.2 | 99.7 | 98.7 | 98.1 | 98.1 | 95.2 | 96.9 | 96.0 | 89.6 | 95.4 | 95.6 | 91.7 |
 HLA-ABC | 99.4 | 99.1 | 99.6 | 95.1 | 98.9 | 99.3 | 99.8 | 99.2 | 99.2 | 99.5 | 99.4 | 98.8 |
 CD86 | 92.3 | 98.5 | 96.3 | 93.4 | 94.6 | 98.9 | 99.7 | 98.8 | 96.6 | 98.8 | 99.2 | 98.2 |
 CD80 | 84.8 | 97.8 | 86.1 | 85.5 | 84.0 | 92.8 | 96.3 | 94.6 | 93.7 | 86.6 | 94.7 | 87.9 |
 CD40 | 87.2 | 84.8 | 82.9 | 84.7 | 81.0 | 89.7 | 93.7 | 84.7 | 85.8 | 87.5 | 92.4 | 84.3 |
 CD83 | 54.3 | 46.8 | 15.7 | 13.8 | 14.5 | 82.1 | 96.0 | 86.9 | 65.6 | 61.2 | 86.8 | 79.4 |
Purity test (lineage negativity %) c | ||||||||||||
CD14 | 1.5 | 2.0 | 8.4 | 0.3 | 0.5 | 0.6 | 1.0 | 1.9 | 1.4 | 1.1 | 1.2 | 1.3 |
CD19 | 1.6 | 0.6 | 0.9 | 0.1 | 0.3 | 1.9 | 0.4 | 0.5 | 0.8 | 0.2 | 0.6 | 0.5 |