ANALYSIS OF PLASMID DNA FROM A PHARMACEUTICAL PERSPECTIVE

The advent of gene therapy and polynucleotide-based vaccines has resul ted in the use of plasmid DNA as a drug substance. Although biological ly (cell or animal) based assays must currently be employed to establi sh the identity and potency of such drugs, we argue that in the future , a combination of microchip-based mutation detection devices combined with an array of chromatographic, electrophoretic, hydrodynamic, and spectroscopic methods can be employed to rigorously establish these pr operties. We review a variety of such methods in this context and also consider the issue of the chemical stability of plasmids. Extensive c omparison is made to protein-based pharmaceuticals with the unique imp ortance of polynucleotide sequence emphasized in comparison to protein tertiary structure.