Table 1.
Summary of qualification results for repeatability and intermediate precision.
| Intermediate precision |
||||||
|---|---|---|---|---|---|---|
| Post-Translational Modifications (PTMs) | Precision-Repeatability (6 preps × 1 injection) | Day-to-Day (3 preps × 1 injection / day, 2 days) | Analyst-to-Analyst (3 preps × 1 injection / analyst, 2 analysts) | Column-to-Column (3 preps × 1 injection / column, 2 columns) | Instrument-to-Instrument (3 preps × 1 injection / instrument, 2 instruments) | |
| CDR isomerization (%) | Mean | 3.8 | 3.9 | 3.6 | 3.9 | 3.9 |
| % CV | 1.9 | 1.2 | 7.4 | 1.7 | 1.4 | |
| CDR deamidation (%) | Mean | 3.1 | 3.2 | 3.2 | 3.2 | 3.2 |
| % CV | 1.4 | 2.3 | 2.4 | 2.4 | 5.0 | |
| PENNY deamidation (%) | Mean | 2.7 | 2.7 | 2.7 | 2.6 | 2.7 |
| % CV | 3.1 | 2.8 | 1.9 | 7.9 | 2.4 | |
| Met-252 oxidation (%) | Mean | 1.8 | 1.8 | 1.8 | 1.9 | 2.0 |
| % CV | 0.9 | 3.3 | 7.0 | 5.0 | 8.0 | |
| HL trisulfide bond (%) | Mean | 2.0 | 2.0 | 2.0 | 2.0 | 1.9 |
| % CV | 3.3 | 1.4 | 1.6 | 2.6 | 2.0 | |
| HL thioether bond (%) | Mean | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
| % CV | 9.3 | 7.1 | 7.6 | 7.5 | 6.4 | |
| Afucosylation (%) | Mean | 17.0 | 17.4 | 17.4 | 17.2 | 16.9 |
| % CV | 0.3 | 2.2 | 2.8 | 1.6 | 0.9 | |