In Vitro Assays
In vitro assays for the detection of adventitious virus are required when using mammalian cell lines for the production of biopharmaceutical and biotechnology products. The ICH Guidelines (Section 3.2.2 from the EMA version of ICH Q5A) requires that samples from the master cell bank, end of production cell bank and bulk harvest be inoculated into cell cultures susceptible to human and animal viruses.
The detector cell lines identified in the guidelines include human and primate cells and cells that are representative of the species and tissue type of the production cell line. For example a CHO master cell bank will be tested using Human MRC-5 cells, Primate Vero cells and Hamster CHO-K1 cells.
BioOutsource’s in vitro assays typically last 14 days for non-primate production cell system such as CHO and 28 days for primate cell production systems such as human cells. The health of the cells are monitored by light microscopy and the monolayers are tested at the end of the incubation period for haemadsorbing viruses.
On some occasions there may be a requirement to add additional cell lines if there is a recognized risk of a particular virus which is not readily detected using the standard detector cells.
Validated Detector Cell Lines
|MRC-5||Human||Lung fibroblast cell commonly used in all in vitro assays to detect human viruses|
|Vero||African Green Monkey||Kidney cell line used to detect a wide variety of viruses|
|324K||Human||Kidney cell line used to specifically identify Mouse minute virus|
|MA104||Rhesus Monkey||Kidney cell line used to detect Rotavirus|
|CHO-K1||Chinese Hamster||Used to detect hamster virus contamination|
|HeLa||Human||Endothelial like cells used to detect human viruses|
|293||Human||Kidney cell line used to detect human viruses|
BioOutsource will report the assay result with a Certificate of Analysis within 7 days following the last observations. Contact our biosafety scientists to discuss your in vitro assay requirements.