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Table 4 Characterization and enumeration of Treg cells before and after enrichment procedures

From: Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

 

Parameter

Validation run

KD patients

LD patients

#01 [KD1]

#02 [KD2]

#03 [LD1]

#04 [LD2]

Mean ± SD

Mean ± SD

Starting material

Viable CD45+ cells (%)

99.4

99.8

99.8

99.9

99.6 ± 0.3

99.9 ± 0.1

Apheresis’ processed volume (mL)

54.4

69.2

50.8

54.8

61.8 ± 10.5

52.8 ± 2.8

WBC concentration (× 106/mL)

194.0

129.5

116.0

44.5

161.8 ± 45.6

80.3 ± 50.6

Treg cells concentration (× 106/mL)

6.32

3.04

1.98

0.82

4.7 ± 2.3

1.4 ± 0.8

Treg cell absolute numbers (× 106)

343.6

210.3

100.6

44.9

277.0 ± 94.3

72.8 ± 39.4

Treg cells (%)

2.6

1.8

1.3

1.6

2.2 ± 0.6

1.5 ± 0.2

CD127 Treg cells (%)

na

1.7

2.0

2.1

1.7 na

2.1 ± 0.1

CD45+CD8+ cells (%)

27.2

34.3

22.2

25.0

30.8 ± 5.0

23.6 ± 2.0

Post-enrichment fraction

Treg cells absolute numbers (× 106)

116.7

91.1

54.4

41.1

103.8 ± 18.0

47.8 ± 9.4

Treg cells purity (%)

84.9

81.3

53.9

70.6

83.1 ± 2.5

62.3 ± 11.8

CD127 Treg cells (%)

65.6

70.1

47.1

66.8

67.9 ± 3.2

57.0 ± 13.9

FoxP3+ Treg cells (%)

84.9

54.1

47.0

59.9

69.5 ± 21.8

53.5 ± 9.1

CD127 FoxP3+ Treg cells (%)

65.4

51.6

45.3

58.9

58.5 ± 9.8

52.1 ± 9.6

CD45+ CD8+ cells (%)

0.8

0.1

0.6

0.1

0.5 ± 0.5

0.4 ± 0.4

Recovery (%)

33.9

43.3

54.1

91.5

38.6 ± 6.6

72.8 ± 26.5

  1. All data are presented as viable cells
  2. SD standard deviation, na not available