Table 3.
Overall viral reduction capacity of the IQYMUNE® manufacturing process
| HIV-1 | BVDV | PRV | SV-40 | EMCV | PPV | |
|---|---|---|---|---|---|---|
| Model for | HIV | HCV | Herpes DNA EV (HBV) | Highly resistant NEV | HAV | Parvovirus B19 |
| Step | ||||||
| Caprylic acid fractionation | ≥4.0 | 5.1 | ≥5.0 | NT | ≥5.6 | 3.7 |
| S/D treatment | ≥4.4 | ≥5.4a | ≥4.3 | NA | NA | NA |
| Anion-exchange chromatography | NT | NT | NT | NT | 1.3 | 3.8 |
| 20 nm nanofiltration | ≥6.4b | ≥6.4 | ≥6.4b | ≥4.8 | ≥5.9 | 3.5 |
| Overall viral reduction capacity | ≥14.8 | ≥16.9 | ≥15.7 | ≥4.8c | ≥12.8 | 11.0 |
BVDV bovine viral diarrhoea virus, EMCV encephalomyocarditis virus, EV enveloped virus, HAV hepatitis A virus, HBV hepatitis B virus, HCV hepatitis C virus, HIV-1 human immunodeficiency virus type 1, NA not applicable, NEV non-enveloped virus, NT not tested, PPV porcine parvovirus, PRV pseudorabies virus, S/D solvent/detergent, SV-40 Simian virus 40
aValue from Sindbis virus (another model for HCV)
bEstimated reduction factor, based on the value measured for BVDV a smaller virus
cOnly one step evaluated