In Vivo Adventitious Agent Test in Eggs (Allantoic Route)
| WHO TRS 978 Annex 3 | FDA Guidance 2010 | Ph. Eur. 5.2.3 | Ph. Eur. 2.6.16 | |
|---|---|---|---|---|
| Test article | 106 viable cells or lysate (For cell banks of avian origin only) | 107 viable cells/mL or equivalent cell lysate 100 doses or 10 mL whichever is greater | 106 viable cells per egg | 100 human doses or 10 mL whichever is greater (Viral seed propagated in avian tissues and viral harvest propagated in primary avian tissues) |
| Animal | 10 eggs 9–11 days old | 10 eggs 10–11 days old | 10 eggs 9–11 days old | 20 or more eggs 9–11 days old |
| Volume per Allantoic route | 0.5 mL per egg | 0.5 mL per egg | Not indicated | 0.5 mL per egg |
| Observation | Not fewer than 5 days | 3 days and passage (+3 days) HA with GP, human type O, and avian RBC | Not less than 5 days HA with mammalian and avian RBC | 7 days |