Manufacturing and characterizing AAV-based vectors for use in clinical studies

Gene Ther. 2008 Jun;15(11):840-8. doi: 10.1038/gt.2008.65. Epub 2008 Apr 17.

Abstract

Recombinant adeno-associated virus (AAV)-based vectors expressing therapeutic gene products have shown great promise for human gene therapy. A major challenge for translation of promising research to clinical development is the manufacture and certification of AAV vectors for clinical use. This review summarizes relevant aspects of current Good Manufacturing Practice, focusing on considerations and challenges specific for recombinant AAV.

Publication types

  • Review

MeSH terms

  • Dependovirus / genetics*
  • Genetic Engineering / standards
  • Genetic Therapy / methods*
  • Genetic Vectors / genetics*
  • Humans
  • Industry
  • Quality Control
  • Recombinant Proteins / genetics

Substances

  • Recombinant Proteins