In Vivo Assays
In vivo assays for adventitious virus are recommended at critical points of the production process. The ICH Guidelines (Section 3.2.3 from the EMA version of ICH Q5A) requires samples from the master cell bank and end of production cell bank to be inoculated into animals. The animals identified in the guidelines include suckling and adult mice and embryonated eggs to reveal viruses that cannot grow in cell cultures. The health of the animals is monitored and any abnormality is investigated.
In some occasions there may be a requirement to test the sample in other animal species if a risk is identified that may not have been detected in the mice or eggs. Other species may include Guinea pigs or Rabbits. BioOutsource can provide consultancy and support including viral risk assessments to help you decide upon additional testing requirements.
The typical in vivo assay in BioOutsource for adventitious virus normally lasts 28 days and BioOutsource will provide a report 14 days following the last observations.