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

Gene Therapy volume 18, pages 210–212 (2011)Cite this article

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Abstract

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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Acknowledgements

We would like to thank Dr Roland Mertelsmann, University Hospital, Freiburg for supporting this study, and CellGenix GmbH, Freiburg for the long-term storage of the GMP-produced serum-free γ-retroviral supernatant. This work was supported by the Bundesministerium für Bildung und Forschung, Grant 01KV9907, by the Deutsche Forschungsgemeinschaft DFG, Grants KA 976/5-1, KA 976/5-2, Ka976/5-3 and Ka976/5-4, and by the Deutsche Krebshilfe Grants 10-1860-GI I and 107217.

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  1. F Herbst and C R Ball: These authors contributed equally to this work.

Authors and Affiliations

  1. Department of Translational Oncology, National Center for Tumor Diseases (NCT) and German Cancer Research Center (DKFZ), Heidelberg, Germany

    F Herbst, C R Ball, O Zavidij, S Fessler, M Schmidt, C von Kalle & H Glimm

  2. Department of Hematology/Oncology, University Medical Center Freiburg, Freiburg, Germany

    H Veelken

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  1. F Herbst
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  2. C R Ball
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  7. C von Kalle
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  8. H Glimm
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Correspondence to C von Kalle.

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Herbst, F., Ball, C., Zavidij, O. et al. 10-Year stability of clinical-grade serum-free γ-retroviral vector-containing medium. Gene Ther 18, 210–212 (2011). https://doi.org/10.1038/gt.2010.126

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