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. 2020 Mar 20;11:482. doi: 10.3389/fimmu.2020.00482

Table 3.

ARI-0001 product characterization.

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.