The invention refers to a new process for the production of purification
of high purity plasmid DNA. The process comprehends: a) the production of
cells containing plasmid DNA, b) the disruption of the cells in order to
obtain a lysate containing plasmid DNA, c) a concentration step by
precipitation with isopropanol, d) a pre-purification and conditioning
step by the addition of ammonium sulphate, e) a purification step using
hydrophobic interaction chromatography, f) a final concentration and/or
buffer exchange step. The process is scaleable, it does not use enzymes
or mutagenic agents and it enables the preparation of plasmid DNA with
pharmaceutical grade, which complies with the requirements of regulatory
agencies. The invention belongs to the technical domain of Biochemical
Engineering/Biotechnology.