Biosafety and product release testing issues relevant to replication-competent oncolytic viruses.
Replication competent oncolytic viruses, like other biological products, are at risk from contamination by bacteria, fungi, mycoplasma and viruses that must be eliminated from the final product. This article reviews the regulatory guidance for the manufacture and testing for oncolytic virus products. A testing strategy covering the testing of cell lines, virus banks, virus harvests and purified product is described.
Wisher
Martin
M
BioReliance, Innovation Park, Stirling, UK. mwisher@bioreliance.com
D000818:Animals; D001688:Biological Products / Q000009:adverse effects / Q000592:standards; D002478:Cells, Cultured; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D017408:Guidelines as Topic; D006801:Humans; D007218:Industrial Microbiology / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D012449:Safety / Q000331:legislation & jurisprudence; D014779:Virus Replication; D014780:Viruses / Q000472:pathogenicity
D001688:Biological Products