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

^aThe viability of the DC vaccine was assessed by flow cytometry after propidium iodide (PI) staining, and is represented as 100−((PI⁺ of sample)−(PI⁺ of control)) (%).

^bThe % represents the cell population in the DC gate (higher forward and side scattering (size and granularity increased)) based on the gating control with calibrating beads and PBMCs.

^cThe % represents marker-positive cell populations based on the isotype control in flow cytometry.