Downstream processing of plasmid DNA for gene therapy and DNA vaccine applications

Interest in producing large quantities of supercoiled plasmid DNA has recen tly increased as a result of the rapid evolution of gene therapy and DNA va ccines. Owing to the commercial interest in these approaches, the developme nt of production and purification strategies for gene-therapy vectors has b een performed in pharmaceutical companies within a confidential environment . Consequently, the information on large-scale plasmid purification is scar ce and usually not available to the scientific community. This article revi ews downstream operations for the large-scale purification of plasmid DNA, describing their principles and the strategy used to attain a final product that meets specifications.