Table 3.
Pat. ID | Cell viability | %CD3+ | %CAR+ | Sterility | Mycoplasma | Endotoxin | Adventitious virus | Transgene copies/cell | RCL | Potency |
---|---|---|---|---|---|---|---|---|---|---|
T01 | 100 | 94.7 | 39.3 | Sterile | Absent | <0.5 EU/ml | Absent | 1.05 | Absent | 13.9 |
T02 | 95 | 96.5 | 28 | Sterile | Absent | <0.5 EU/ml | Absent | 0.92 | Absent | 6.0 |
T03 | 90 | 96.0 | 30 | Sterile | Absent | <0.5 EU/ml | Absent | 0.97 | Absent | 2.7 |
T04 | 98 | 98.1 | 22.8 | Sterile | Absent | <0.5 EU/ml | Absent | 0.66 | Absent | 17.2 |
T05 | 93 | 98.4 | 22.9 | Sterile | Absent | <0.5 EU/ml | Absent | 0.9 | Absent | 41.4 |
T06 | 96 | 87.1 | 43.6 | Sterile | Absent | <0.5 EU/ml | Absent | 1.55 | Absent | 0.6 |
T07 | 96 | 97.3 | 20.4 | Sterile | Absent | <0.5 EU/ml | Absent | 0.73 | Absent | 18.6 |
T08 | 92 | 98.7 | 20.7 | Sterile | Absent | <0.5 EU/ml | Absent | 1.62 | Absent | 21.4 |
T09 | 100 | 99.1 | 20.6 | Sterile | Absent | <0.5 EU/ml | Absent | 0.77 | Absent | 8.7 |
T10 | 98 | 98.7 | 14.5* | – | – | – | – | – | – | – |
T11 | 94 | 99.7 | 25 | Sterile | Absent | <0.5 EU/ml | Absent | 2.31 | Absent | 0.04 |
T12 | 98 | 99.4 | 20 | Sterile | Absent | <0.5 EU/ml | Absent | 0.43 | Absent | 14.4 |
T13 | 95 | 99.2 | 20.4 | Sterile | Absent | <0.5 EU/ml | Absent | 0.57 | Absent | 3.5 |
T14 | 98 | 99.2 | 62.2 | Sterile | Absent | <0.5 EU/ml | Absent | 1.99 | Absent | 0.01 |
T15 | 93 | 97.5 | 34.4 | Sterile | Absent | <0.5 EU/ml | Absent | 1.98 | Absent | 1.4 |
T16 | 91 | 98.7 | 26.6 | Sterile | Absent | <0.5 EU/ml | Absent | 1.46 | Absent | 0.1 |
T17 | 96 | 94.8 | 26 | Sterile | Absent | <0.5 EU/ml | Absent | 1.47 | Absent | 0.2 |
T19 | 93 | 90.6 | 22.6 | Sterile | Absent | <0.5 EU/ml | Absent | 0.99 | Absent | 0.3 |
T20 | 94 | 98.3 | 20.8 | Sterile | Absent | <0.5 EU/ml | Absent | 1.15 | Absent | 0.02 |
T21 | 91 | 99.4 | 48.2 | Sterile | Absent | <0.5 EU/ml | Absent | 1.59 | Absent | 0.0 |
T22 | 82 | 97.3 | 44.1 | Sterile | Absent | <0.5 EU/ml | Absent | 2.1 | Absent | 0.0 |
T24 | 97 | 99.7 | 23.8 | Sterile | Absent | <0.5 EU/ml | Absent | 1.55 | Absent | 4.18 |
T25 | 94 | 98.2 | 41.5 | Sterile | Absent | <0.5 EU/ml | Absent | 2.92 | Absent | 0.06 |
T26 | 97 | 98.5 | 23 | Sterile | Absent | <0.5 EU/ml | Absent | 0.4 | Absent | 28.0 |
T27 | 98 | 96.5 | 23.2 | Sterile | Absent | <0.5 EU/ml | Absent | 0.62 | Absent | 4.3 |
T30 | 95 | 85.7 | 26 | Sterile | Absent | <0.5 EU/ml | Absent | 2.08 | Absent | 0.2 |
T32 | 97 | 98.2 | 35.6 | Sterile | Absent | <0.5 EU/ml | Absent | 1.93 | Absent | 0.2 |
T34 | 94 | 99.1 | 71.5 | Sterile | Absent | <0.5 EU/ml | Absent | 2.93 | Absent | 0.02 |
Value below acceptance criteria.