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Table 1 Product properties

From: Automation of cellular therapy product manufacturing: results of a split validation comparing CD34 selection of peripheral blood stem cell apheresis product with a semi-manual vs. an automatic procedure

  Split run #1 Split run #2 Split run #3
CliniMACS Prodigy CliniMACS Prodigy CliniMACS Prodigy
Apheresis product
 Volume (ml) 70 66 100 100 80 80
 WBC (×106/ml) 269.8 272.6 268.3 268.3 287.4 287.4
 WBC (×109) 18.9 18 26.8 26.8 23 23
 Hkt (%) 2.5 2.5 1.3 1.3 1.7 1.7
 Plt (×106/ml) 2740 2740 1934 1934 1971 1971
 Plt total (×109) 191.8 180.8 193.4 193.4 157.7 157.7
 T-cells (×106) 6818 6428 4587 4587 3670 3670
 CD4+ (% of CD3 +) 70 70 58 58 58 58
 CD8+ (% of CD3 +) 30 30 42 42 42 42
 CD34+ cells (%) 2.2 2.2 2.1 2.1 2.1 2.1
 CD34+ cells (×106) 417.8 393.3 572.6 572.6 458.1 458.1
 B-cells (×106) 1813 1709 1550 1550 1240 1240
Non-target fraction
 Volume (ml) 298 393 328 389 301 394
 WBC (×109) 16.1 14.6 23.8 22.3 14.5 16.8
 CD34+ cells (%) 0.2 0.2 0.2 0.2 0.3 0.2
 CD34+ cells (×106) 33 31 49 44 47 37
Target fraction
 Volume (ml) 40 78 41 82 39 76
 WBC (×109) 0.27 0.2 0.39 0.39 0.24 0.29
 Plt (x106/ml) 4 4 7 8 5 7
 T-cells (×106) 0.08 0.47 0.05 0.2 0.06 0.21
 CD4+ (% of CD3 +) 50 50 9 43 11 24
 CD8+ (% of CD3 +) 50 50 91 57 89 76
 CD34+ cells (%) 97 96.1 99 98.2 98.8 98
 CD34+ cells (×106) 265.7 191 387.9 379.9 234 273.4
 B-cells (×106) 0.2 0.47 0.16 0.74 0.08 0.38
 NK-cells (K/µl) n.d. n.d. n.d. n.d. n.d. n.d.
 Monocytes (K/µl) 0.004 0.022 0.012 0.038 0.009 0.029
 Ratio T:CD34+ 3.01−4 2.45−3 1.27−4 5.18−4 2.67−4 7.73−4
 T-cells/4 × 106 CD34+ 1204.5 9803.1 507.4 2072 1066.5 3090.6
 B-cells/4 × 106 CD34+ 3011.1 9803.1 1691.4 7770.1 1333.1 5558.6
 Recovery CD34+ (%) 63.6 48.6 67.7 66.3 51.1 59.7
 B-cell depletion 1.10−4 2.74−4 1.06−4 4.76−4 6.29−5 3.07−4
 T-cell depletion 1.17−5 7.28−5 1.07−5 4.29−5 1.70−5 5.76−5
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