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

Gene Ther. 2011 Feb;18(2):210-2. doi: 10.1038/gt.2010.126. Epub 2010 Nov 11.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Culture Media, Serum-Free*
  • Genetic Vectors*
  • Hematopoietic Stem Cells*
  • Leukemia Virus, Gibbon Ape / genetics*
  • Preservation, Biological*
  • Time Factors
  • Transduction, Genetic*

Substances

  • Culture Media, Serum-Free