Effects of Temperature on Low-pH Retrovirus Inactivation in the Presence of Four Lilly Process Intermediates. LRF, Log10 Reduction Factor
| Product | Isotype | Buffer | LRF Achieved by 60 min Treatment at Indicated pH and Temperature | ||
|---|---|---|---|---|---|
| pH: ∼3.65 T = Ambient | pH: ∼3.85 T = 15 °C | pH: ∼3.85 T = 25 °C | |||
| mAb A | IgG1 | Succinate | >6.6 | >6.4 | >6.5 |
| mAb B | IgG1 | Citrate | 5.7 | 2.9 | 6.0 |
| mAb C | IgG4 | Citrate | >5.3 | 3.4 | >4.3 |
| Protein X | Fc-Fusion | Citrate | >5.4 | >5.3 | >5.0 |