In vivo testing for adventitious viruses in live embryonated chicken eggs:
Protocol # CB109, Turnaround Time: 4-6 weeks
The purpose of this study is to evaluate test material from a biological source for the presence of adventitious viruses that do not cause visible effects in a cell culture. The test article is inoculated into live embryonated eggs via the yolk sac and allantoic routes and the eggs are incubated at 37 C. The viability of the embryos during the incubation period is an indicator to whether the biological product contains harmful viruses or not. At the conclusion of the studies, the contents of the eggs are collected and subjected to hemagglutination using red blood cells from three different species at three different temperatures and the results are recorded.
Observations are recorded and the data is described in detail in a final report that the client receives. The studies are conducted under GLP conditions and in compliance with FDA regulations for testing biologicals.
The sponsor will be required to review and approve a protocol prior to study initiation. Please fill out the sample submission form below in either Word or PDF format and send along with the samples.