In Vivo Adventitious Agent Test—Adult Mice
| WHO TRS 978 Annex 3 | FDA Guidance 2010 | Ph. Eur. 5.2.3 | Ph. Eur. 2.6.16 | |
|---|---|---|---|---|
| Test article | 107 viable cells or lysate | 107 viable cells/mL or equivalent cell lysate | 107 viable cells divided equally | Viral seed lot |
| Animal | 10 adult mice 15–20 g | 20 adult mice 15–20 g | 10 adult mice 15–20 g | 10 adult mice 15–20 g |
| Route | i.c. 0.03 mL in some countries i.c. 106 cells/mouse 10 mice if LCMV is a concern | i.p. 0.5 mL i.c. 0.03 mL | i.m. (no volume indicated) i.c. 106 cells/mouse 10 mice for LCMV | i.p. 0.5 mL i.c. 0.03 mL |
| Observation | 4 weeks or 21 days | 21 days | 4 weeks | 21 days |