Replication-competent lentivirus analysis of clinical grade vector products

Kenneth Cornetta, Jing Yao, Aparna Jasti, Sue Koop, Makhaila Douglas, David Hsu, Larry A. Couture, Troy Hawkins, Lisa Duffy

Research output: Contribution to journalArticle

32 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)557-566
Number of pages10
JournalMolecular Therapy
Issue number3
StatePublished - Mar 2011

ASJC Scopus subject areas

  • Molecular Medicine
  • Molecular Biology
  • Genetics
  • Pharmacology
  • Drug Discovery

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    Cornetta, K., Yao, J., Jasti, A., Koop, S., Douglas, M., Hsu, D., Couture, L. A., Hawkins, T., & Duffy, L. (2011). Replication-competent lentivirus analysis of clinical grade vector products. Molecular Therapy, 19(3), 557-566.