Virus Bulk Harvest
The bulk harvest or lot is derived from the production process without any downstream processing and is the stage at which adventitious agents are most likely to be found. As such, this where the most extensive adventitious agent testing should be performed. This should include testing for non-cultivatable mycoplasmas (and spiroplasma where appropriate) and adventitious agent testing by in vitro methods. This should also include in vivo testing if the cells and vaccine seeds have not already been tested, for example in the case of viruses produced on primary cells. Similarly if primary cells are used a test for Mycobacterium tuberculosis may be performed if appropriate.
PERT testing for reverse transcriptase may be performed if there is potential for the induction of retroviruses during virus production.
Contact us to discuss your virus bulk harvest testing requirements.