Table 5.
Protein L ligand leakage, host cell proteins and endotoxin levels determined by commercial kits after two-step purification.
Purification Step | Fraction | Protein L Concentration (ng/mL) | Accepted Range |
---|---|---|---|
First Step (AC) | Load | – | Below 6.0 ng/mL |
Elution | 5.36 | ||
Second Step (CEX) | Elution | 3.76 | |
Purification Step | Fraction | HCP Concentration (ng/mL) | |
First Step (AC) | Load | 1.67 x 106 | Below 100 ng/mL |
Elution | 661 | ||
Second Step (CEX) | Elution | 16.8 | |
Purification Step | Fraction | Endotoxin Concentration (EU/mL) | |
First Step (AC) | Load | 1788 | Below 0.5 EU/mL |
Elution | 0.065 | ||
Second Step (CEX) | Elution | 0.031 |