Table 1.
Summary of assay qualification results. The average results ± 3 SDs and the RSDs are presented from subunit mass experiments using two different columns performed on three different days by two different analysts.
| Non-oxidized scFc (%) |
Total Oxidized scFc (%)1 | ||||
|---|---|---|---|---|---|
| Parameter | Average ± 3SD | RSD | Average ± 3SD | RSD | n |
| Column-to-Column Variability | 97.9 ± 0.5 | 0.2 | 2.1 ± 0.6 | 9.8 | 12 |
| Day-to-Day Variability | 98.0 ± 0.5 | 0.2 | 2.0 ± 0.5 | 7.9 | 18 |
| Analyst-to-Analyst Variability | 98.0 ± 0.2 | 0.1 | 2.0 ± 0.2 | 3.1 | 12 |
| Intermediate Precision | 97.9 ± 0.5 | 0.2 | 2.1 ± 0.5 | 8.4 | 30 |
1
The sum of all oxidized species is expressed as a percentage of total scFc (non-oxidized + oxidized species). n = number of experiments.