TABLE 4.
Virus Inactivation/Removal in Hizentra™*
| HIV-1 | PRV | BVDV | WNV | EMCV | MVM | |
|---|---|---|---|---|---|---|
| Virus property | ||||||
| Genome | RNA | DNA | RNA | RNA | RNA | DNA |
| Envelope | Yes | Yes | Yes | Yes | No | No |
| Size (nm) | 80–100 | 120–200 | 50–70 | 50–70 | 25–30 | 18–24 |
| Manufacturing step | Mean LRF | |||||
| pH 4 incubation | ≥5.4 | ≥5.9 | 4.6 | ≥7.8 | nt | nt |
| Depth filtration | ≥5.3 | ≥6.3 | 2.1 | 3.0 | 4.2 | 2.3 |
| Virus filtration | ≥5.3 | ≥5.5 | ≥5.1 | ≥5.9 | ≥5.4 | ≥5.5 |
| Overall reduction (Log10 units) | ≥16.0 | ≥17.7 | ≥11.8 | ≥16.7 | ≥9.6 | ≥7.8 |
Abbreviations: BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; EMCV, encephalomyocarditis virus, a model for hepatitis A virus; HIV-1, human immunodeficiency virus type 1, a model for HIV-1 and HIV-2; LRF, log10 reduction factor; MVM, minute virus of mice, a model for a small highly resistant non-enveloped DNA virus (e.g., parvovirus); nt, not tested; PRV, pseudorabies virus, a nonspecific model for large enveloped DNA viruses (e.g., herpes virus); WNV, West Nile virus.
*
The virus clearance of human parvovirus B19 was investigated experimentally at the pH 4 incubation step. The estimated LRF obtained was ≥5.3.