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10-year stability of clinical-grade serum-free γ-retroviral vector-containing medium

More than 10 years ago, we developed an efficient protocol for serum-free retroviral transduction of human hematopoietic stem cells derived from mobilized peripheral blood. After upscaling of the methodology, serum-free retroviral gibbon-ape leukemia virus (GALV) pseudotype PG13/LN vector supernatan...

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Bibliographic Details
Main Authors: Herbst, Friederike (Author) , Ball, Claudia R. (Author) , Zavidij, Oksana (Author) , Fessler, Sylvia (Author) , Schmidt, Manfred (Author) , Veelken, Hendrik (Author) , Kalle, Christof von (Author) , Glimm, Hanno (Author)
Format: Article (Journal)
Language:English
Published: [2011]
In: Gene therapy
Year: 2011, Volume: 18, Issue: 2, Pages: 210-212
ISSN:1476-5462
DOI:10.1038/gt.2010.126
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1038/gt.2010.126
Verlag, lizenzpflichtig, Volltext: https://www.nature.com/articles/gt2010126
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Author Notes:F. Herbst, C.R. Ball, O. Zavidij, S. Fessler, M. Schmidt, H. Veelken, C. von Kalle and H. Glimm
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Summary:More than 10 years ago, we developed an efficient protocol for serum-free retroviral transduction of human hematopoietic stem cells derived from mobilized peripheral blood. After upscaling of the methodology, serum-free retroviral gibbon-ape leukemia virus (GALV) pseudotype PG13/LN vector supernatant produced under strict good manufacturing practice (GMP) conditions was used in the first clinical gene-marking trial in Germany. In this study, we analyzed the titer and transduction efficiency of this serum-free clinical-grade retroviral supernatant 10 years after production to evaluate the long-term stability. Long-term storage and transport on dry ice resulted in modestly decreased titers and levels of transduction efficiency in CD34+ cells ranging from 38.4 to 49.1%. We conclude that the stability of retroviral vectors in serum-free medium allows extended storage and distribution of approved clinical-grade retroviral vector stocks to distant sites in multicenter clinical trials.
Item Description:Published: 11 November 2010
Gesehen am 06.10.2022
Physical Description:Online Resource
ISSN:1476-5462
DOI:10.1038/gt.2010.126

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