Production of Plasmid DNA in Industrial Quantities According to cGMP Guidelines

Within the last five years, the exponential growth of research activities on the development of genetic vaccination and gene therapy has made it necessary to develop an easy, cost-effective, industrial scale process for production of plasmid DNA (see Note 1 ). One main issue is that the process should conform to cGMP guidelines and be acceptable to the FDA or other national regulatory agencies. The cGMP environment should be implemented independently of the intended use of the DNA product.