Biosafety and product release testing issues relevant to replication-competent oncolytic viruses

Cancer Gene Ther. 2002 Dec;9(12):1056-61. doi: 10.1038/sj.cgt.7700536.


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.

Publication types

  • Review

MeSH terms

  • Animals
  • Biological Products* / adverse effects
  • Biological Products* / standards
  • Cells, Cultured
  • Drug Contamination / legislation & jurisprudence
  • Drug Contamination / prevention & control
  • Guidelines as Topic
  • Humans
  • Industrial Microbiology / legislation & jurisprudence
  • Industrial Microbiology / methods
  • Industrial Microbiology / standards
  • Safety* / legislation & jurisprudence
  • Virus Replication*
  • Viruses* / pathogenicity


  • Biological Products