Table 3.
Log10 reduction factors of model viruses observed during laboratory experiments of IVIG production (Carimune NF®)
| Process (step in Fig. 1) | Mechanism | HIV | PRV | BVDV | SIN | BEV |
|---|---|---|---|---|---|---|
| Fractionation/depth filtration (1) | p | 4.0 | 3.6 | 1.5 | 3.2 | 3.4 |
| Fractionation/depth filtration (2) | p | 5.3 | 4.7 | 1.6 | 4.6 | 4.1 |
| DV50 Virusfiltration (3) | n | >4.9 | >4.4 | >4.5 | >7.5 | >5.1 |
| pH 4 pepsin inactivation (4) | i | >6.1 | >5.3 | >4.4 | >6.7 | <1* |
| Clarification/depth filtration (5) | p | 4.0 | 4.7 | 3.0 | 2.9 | 3.8 |
| Clarification/depth filtration (6) | p | 2.2 | 3.0 | <1* | 1.7 | 2.8 |
| Total reduction | >26.5 | >25.7 | >15.0 | >26.6 | >19.2 | |
Mechanism: p: partitioning; i: inactivation; n: virusfiltration. *Not significant and not included in total reduction.