Table 2 Quality control of 12 DC vaccines

From: A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma

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

  1. 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)) (%).
  2. 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.
  3. cThe % represents marker-positive cell populations based on the isotype control in flow cytometry.