Table 1.
Donor | PBMCs seeded (×106) | CD3+ T-cells seeded (%) | Total cells harvested (×109) | Viability (%) | CD3+ T-cells harvested (%) | CD3+ T- cell fold-expansion | CD3+ T-cell doubling time (h) | CD3+ T-cells population doublings | Cell culture concentration at harvest (×106 cells/mL)a |
---|---|---|---|---|---|---|---|---|---|
1 | 30 | 36.9 | 14.9 | 91.9 | 94.2 | 1268 | 20.7 | 10.3 | 120 |
2 | 46.6 | 13.9 | 92.5 | 96.1 | 956 | 21.6 | 9.9 | 112 | |
3 | 55.0 | 16.1 | 93.8 | 97.5 | 951 | 21.6 | 9.9 | 130 | |
4 | 32.5 | 16.2 | 94.0 | 96.0 | 1595 | 20.1 | 10.6 | 131 | |
5 | 23.6 | 13.1 | 92.5 | 96.6 | 1787 | 19.8 | 10.8 | 106 | |
Mean | 38.9 | 14.8 | 93.7 | 96.1 | 1311 | 20.7 | 10.3 | 120 | |
SD | 12.2 | 1.3 | 2.0 | 1.2 | 376 | 0.8 | 0.4 | 11 | |
% CV | 31.4 | 9.1 | 2.1 | 1.3 | 29 | 4.0 | 4.1 | 9.1 | |
1 | 85 | 36.9 | 27.8 | 91.0 | 91.9 | 815 | 19.6 | 9.7 | 224 |
2 | 46.6 | 24.6 | 92.0 | 94.3 | 586 | 20.6 | 9.2 | 198 | |
3 | 55.0 | 26.9 | 94.0 | 94.3 | 543 | 20.3 | 9.1 | 217 | |
4 | 32.5 | 23.5 | 93.0 | 92.7 | 789 | 19.2 | 9.6 | 190 | |
5 | 23.6 | 22.9 | 90.3 | 94.5 | 1079 | 18.8 | 10.1 | 185 | |
Mean | 38.9 | 25.1 | 92.1 | 93.5 | 762 | 19.9 | 9.5 | 203 | |
SD | 12.2 | 2.1 | 1.5 | 1.2 | 214 | 0.8 | 0.4 | 17 | |
% CV | 31.4 | 8.5 | 1.6 | 1.3 | 28 | 4.2 | 4.1 | 8.5 |
Fold expansion, doubling times and population doublings were calculated as described in “Materials and methods”
aTotal cell concentration at harvest was calculated from the total cells harvested and the volume within the fibers of the bioreactor (124 mL)