Table 3.
Content | Purity defined as AUC (% of total AUC) | |||
---|---|---|---|---|
Berinert | Cetor | Cinryze | Ruconest | |
High-molecular-weight proteins, mean | 2.8 | 11.0 | 10.2 | 0.6 |
Batch 1 | 2.8 | 11.0 | 12.2 | 0.6 |
Batch 2 | 2.8 | NA | 8.2 | 0.6 |
C1-INH protein, mean (standard method)* | 94.7 | 67.4 | 69.6 | 98.6 |
Batch 1 | 94.6 | 67.4 | 71.3 | 98.6 |
Batch 2 | 94.9 | NA | 68.0 | 98.6 |
C1-INH protein, mean (adapted method)† | 97.0 | 88.6 | 89.5 | 98.6 |
Batch 1 | 97.0 | 88.6 | 87.6 | 98.6 |
Batch 2 | 97.0 | NA | 91.5 | 98.6 |
Low-molecular-weight proteins, mean | 0.2 | 0.3 | 0.3 | 0.8 |
Batch 1 | 0.2 | 0.3 | 0.2 | 0.8 |
Batch 2 | 0.2 | NA | 0.3 | 0.8 |
Amount of C1-INH protein evaluated with the standard Berinert method at an elution time of 13.5 to 15.0 minutes.
Amount of C1-INH protein evaluated with the adapted Berinert method to cover peak split in Cetor and Cinryze at an elution time of 13.5 to 17.0 minutes.