期刊
GENE THERAPY
卷 18, 期 2, 页码 210-212出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/gt.2010.126
关键词
retroviral vectors; long-term stability; serum-free medium
类别
资金
- Bundesministerium fur Bildung und Forschung [01KV9907]
- Deutsche Forschungsgemeinschaft DFG [KA 976/5-1, KA 976/5-2, Ka976/5-3, Ka976/5-4]
- Deutsche Krebshilfe [10-1860-GI I, 107217]
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. Gene Therapy (2011) 18, 210-212; doi:10.1038/gt.2010.126; published online 11 November 2010
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