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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