Skip to main content

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