1024 Monoclonal antibody
Nominal conc. (ng/mL) Calculated conc. (ng/mL) Accuracy (%Bias) Calculated conc. (ng/mL) Accuracy (%Bias) Calculated conc. (ng/mL) Accuracy (%Bias)
150.0 136.4 -9.0 155.4 3.6 146.8 -2.1
250.0 271.0 8.4 228.9 -8.5 151.4 *Dev
500.0 506.5 1.3 516.7 3.3 549.2 9.8
1000.0 1064.2 6.4 1060.6 6.1 980.0 -2.0
2500.0 2302.6 -7.9 2457.1 -1.7 2421.1 -3.2
5000.0 5098.9 2.0 4769.3 -4.6 4582.0 -8.4
7500.0 7092.6 -5.4 7390.1 -1.5 7835.3 4.5
10000.0 10427.8 4.3 10321.9 3.2 10135.6 1.4
992 Monoclonal antibody
Nominal conc. (ng/mL) Calculated conc. (ng/mL) Accuracy (%Bias) Calculated conc. (ng/mL) Accuracy (%Bias) Calculated conc .(ng/mL) Accuracy (%Bias)
150.0 141.1 -5.9 152.6 1.7 128.8 -14.1
250.0 265.5 6.2 222.7 -10.9 222.4 -11.0
500.0 436.1 -12.8 513.3 2.7 584.6 16.9
1000.0 1147.0 14.7 1119.4 11.9 1122.2 12.2
2500.0 2721.4 8.9 2428.7 -2.9 2466.2 -1.4
5000.0 4489.4 -10.2 4730.4 -5.4 4855.1 -2.9
7500.0 6643.5 -11.4 7646.6 2.0 7514.5 0.2
10000.0 11056.0 10.6 10086.2 0.9 10006.2 0.1
Total MABS
Nominal conc. (ng/mL) Calculated conc. (ng/mL) Accuracy (%Bias) Calculated conc. (ng/mL) Accuracy (%Bias) Calculated conc. (ng/mL) Accuracy (%Bias)
300.0 290.1 -3.3 297.9 -0.7 240.1 -20.0
500.0 527.1 5.4 486.3 -2.7 349.4 *Dev
1000.0 935.2 -6.5 1039.0 3.9 1101.4 10.1
2000.0 2140.5 7.0 2156.1 7.8 2250.6 12.5
5000.0 4707.9 -5.8 4589.8 -8.2 4977.7 -0.4
10000.0 10526.8 5.3 9673.2 -3.3 9922.9 -0.8
15000.0 14727.5 -1.8 15267.2 1.8 14693.3 -2.0
20000.0 19944.9 -0.3 20290.7 1.5 20114.1 0.6
*Dev: Deviation from nominal concentration
Table 12: Individual standard curve concentration data of the LC-MS/MS analysis of 1024 mAb, 992 mAb and total mAbs in monkey serum.