Screening clinical cell products for replication competent retrovirus: The National Gene Vector Biorepository experience Journal Article


Authors: Cornetta, K.; Duffy, L.; Feldman, S. A.; Mackall, C. L.; Davila, M. L.; Curran, K. J.; Junghans, R. P.; Tang, J. Y.; Kochenderfer, J. N.; O'Cearbhaill, R.; Archer, G.; Kiem, H. P.; Shah, N. N.; Delbrook, C.; Kaplan, R.; Brentjens, R. J.; Rivière, I.; Sadelain, M.; Rosenberg, S. A.
Article Title: Screening clinical cell products for replication competent retrovirus: The National Gene Vector Biorepository experience
Abstract: Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment. In this study, we reviewed 286 control (n = 4) and transduced cell products (n = 282) screened for RCR in the National Gene Vector Biorepository. The transduced cell samples were submitted from 14 clinical trials. All vector products were previously shown to be negative for RCR prior to use in cell transduction. After transduction, all 282 transduced cell products were negative for RCR. In addition, 241 of the clinical trial participants were also screened for RCR by analyzing peripheral blood at least 1 month after infusion, all of which were also negative for evidence of RCR infection. The majority of vector products used in the clinical trials were generated in the PG13 packaging cell line. The findings suggest that screening of the retroviral vector product generated in PG13 cell line may be sufficient and that further screening of transduced cells does not provide added value. © 2018 The Author(s)
Keywords: lentivirus; retrovirus; replicating virus; safety testing
Journal Title: Molecular Therapy - Methods & Clinical Development
Volume: 10
ISSN: 2329-0501
Publisher: Nature Publishing Group  
Date Published: 2018-08-21
Start Page: 371
End Page: 378
Language: English
DOI: 10.1016/j.omtm.2018.08.006
PROVIDER: scopus
PMCID: PMC6134358
PUBMED: 30211249
DOI/URL:
Notes: Article -- Export Date: 1 October 2018 -- Source: Scopus
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MSK Authors
  1. Renier J Brentjens
    187 Brentjens
  2. Kevin Joseph Curran
    56 Curran
  3. Michel W J Sadelain
    449 Sadelain
  4. Isabelle C Riviere
    158 Riviere