Virus Safety Margins for Cell-Derived and Plasma-Derived Medicinal Products
| CHO RVLP | NS0 Retrovirus | Plasma-derived Viruses | |
|---|---|---|---|
| Virus in Starting Material | 104–9 vpa/mL | up to 1010 vp/mL and ∼101–2 ffua/mL | ≤LOQa,b |
| Infectious Virus | No | Yes | HIV, HCV, HBV, HAV, B19, etc. |
| Virus Pathogenesis in Humans | No | Unknown | Yes |
| Virus Transmission History | No | No | Yes |
| Virus Clearance Target | ≤1 vp/106 doses (ICH Q5A – Appendix 5) | ≤1 vp/106 doses (ICH Q5A – Appendix 5) | ≤1 vp/106 doses (EMA/CHMP/BWP/706271/2010) |