Replication-competent lentivirus analysis of clinical grade vector products

Mol Ther. 2011 Mar;19(3):557-66. doi: 10.1038/mt.2010.278. Epub 2010 Dec 21.

Abstract

Lentiviral vectors are now in clinical trials for a variety of inherited and acquired disorders. A challenge for moving any viral vector into the clinic is the ability to screen the vector product for the presence of replication-competent virus. Assay development for replication-competent lentivirus (RCL) is particularly challenging because recombination of vector packaging plasmids and cellular DNA leading to RCL has not been reported with the current viral vector systems. Therefore, the genomic structure of a RCL remains theoretical. In this report, we describe a highly sensitive RCL assay suitable for screening vector product and have screened large-scale vector supernatant, cells used in vector production, and cells transduced with clinical grade vector. We discuss the limitations and challenges of the current assay, and suggest modifications that may improve the suitability of this assay for screening US Food and Drug Administration (US FDA)-licensed products.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cell Line
  • Enzyme-Linked Immunosorbent Assay / methods
  • Genetic Vectors / genetics
  • Genetic Vectors / isolation & purification*
  • Genetic Vectors / standards*
  • Genetic Vectors / therapeutic use
  • HEK293 Cells
  • HIV Core Protein p24 / immunology
  • Humans
  • Lentivirus / genetics
  • Lentivirus / isolation & purification*
  • Quality Control
  • Recombination, Genetic
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Virus Replication*

Substances

  • HIV Core Protein p24