A reporter system for replication-competent gammaretroviruses: the inGluc-MLV-DERSE assay

Gene Ther. 2013 Feb;20(2):169-76. doi: 10.1038/gt.2012.18. Epub 2012 Mar 8.

Abstract

Although novel retroviral vectors for use in gene-therapy products are reducing the potential for formation of replication-competent retrovirus (RCR), it remains crucial to screen products for RCR for both research and clinical purposes. For clinical-grade gammaretrovirus-based vectors, RCR screening is achieved by an extended S(+)L(-) or marker-rescue assay, whereas standard methods for replication-competent lentivirus detection are still in development. In this report, we describe a rapid and sensitive method for replication-competent gammaretrovirus detection. We used this assay to detect three members of the gammaretrovirus family and compared the sensitivity of our assay with well-established methods for retrovirus detection, including the extended S(+)L(-) assay. Results presented here demonstrate that this assay should be useful for gene-therapy product testing.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, N.I.H., Intramural

MeSH terms

  • Animals
  • Genes, Reporter / genetics
  • Genetic Vectors
  • HEK293 Cells
  • Humans
  • Leukemia Virus, Murine / genetics
  • Leukemia Virus, Murine / isolation & purification*
  • Luciferases / genetics
  • Luciferases / metabolism
  • Mice
  • NIH 3T3 Cells
  • Real-Time Polymerase Chain Reaction
  • Virus Replication*

Substances

  • Luciferases