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...
Gespeichert in:
| Hauptverfasser: | , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
[2011]
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| In: |
Gene therapy
Year: 2011, Jahrgang: 18, Heft: 2, Pages: 210-212 |
| ISSN: | 1476-5462 |
| DOI: | 10.1038/gt.2010.126 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1038/gt.2010.126 Verlag, lizenzpflichtig, Volltext: https://www.nature.com/articles/gt2010126 
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| Verfasserangaben: | F. Herbst, C.R. Ball, O. Zavidij, S. Fessler, M. Schmidt, H. Veelken, C. von Kalle and H. Glimm |
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| 245 | 1 | 0 | |a 10-year stability of clinical-grade serum-free γ-retroviral vector-containing medium |c F. Herbst, C.R. Ball, O. Zavidij, S. Fessler, M. Schmidt, H. Veelken, C. von Kalle and H. Glimm |
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| 520 | |a 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. | ||
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