Table 2. Virus reduction efficacy of the manufacturing process of anti-COVID-19 hyperimmune immunoglobulin.
| Virus inactivation/removal step | Virus reduction factor, log10 | |||||||
|---|---|---|---|---|---|---|---|---|
| Enveloped viruses | Nonenveloped viruses | |||||||
| DHBV | HIV-1 | HCV | HBV | BVDV | B19V | PPV | EMCV | |
| Solvent/detergent treatment | ≥5.0 | ≥6.0 | – | – | ≥4.0 | – | – | – |
| Ethanol fractionation | – | – | ≥4.0 | ≥5.0 | – | ≥4.0 | – | – |
| Low-pH incubation | ≥5.0 | ≥4.0 | – | – | ≥5.5 | – | – | – |
| Chromatography | – | – | ≥2.0 | ≥3.5 | – | ≥3.5 | – | – |
| Nanofiltration (20 nm) | – | ≥4.0 | ≥4.0 | ≥4.0 | ≥5.0 | ≥4.0 | ≥5.0 | ≥5.5 |
| Global reduction factor | ≥10.0 | ≥14.0 | ≥10.0 | ≥12.5 | ≥14.5 | ≥11.5 | ≥5.0 | ≥5.5 |
B19V: Human parvovirus B19; BVDV: Bovine viral diarrhea virus; DHBV: Duck hepatitis B virus; EMCV: Encephalomyocarditis virus; PPV: Porcine parvovirus.