Table 2 A Inter-day intermediate precision of PMF-EIC method with mAb X containing ~ 0.1% of E262K substitution. The % substitution is calculated using Eq. (1). B Accuracy of PMF-EIC method at ~ 400 pmol and ~ 8 pmol column load.
Intermediate inter-day precision | % E262K | ||||
|---|---|---|---|---|---|
A | |||||
Day 1 | 0.08 | ||||
Day 2 | 0.12 | ||||
Day 3 | 0.14 | ||||
Day 4 | 0.10 | ||||
Day 5 | 0.12 | ||||
Day 6 | 0.09 | ||||
Average | 0.11 | ||||
% CV | 18.8 | ||||
Column load | AUC of EK peptide | AUC of native peptide | %E262K | Average %E262K | % CV |
|---|---|---|---|---|---|
B | |||||
~ 400 pmol | 130,195,529 | 331,971,597 | 28.2 | 28.8 | 5.7 |
128,506,560 | 296,820,826 | 30.2 | |||
131,613,201 | 339,193,814 | 28.0 | |||
~ 8 pmol | 3,463,371 | 2,633,558 | 56.8 | 47.5 | 44.3 |
1,958,042 | 3,970,226 | 33.0 | |||
1,918,275 | 1,717,359 | 52.8 | |||
