PROCESS FOR PRODUCING ENDOTOXIN-FREE OR ENDOTOXIN-POOR NUCLEIC ACIDS AND/OR OLIGONUCLEOTIDES FOR GENE THERAPY

摘要

A process for the isolation and purification of nucleic acids and/or oligonucleotides for use in gene therapy wherein said nucleic acids and/or oligonucleotides are isolated or purified from an essentially biological source, characterized in that said essentially biological sources are lysed, the frac-tions obtained are optionally freed or depleted from the remainder of said biological sources by per se known mechanical methods, such as centrifugation, filtration; - the fractions thus treated are subsequently treated with affinity chromatographic material or with inorganic chromatographic material for the removal of endotoxins; followed by - isolation of said nucleic acids and/or oligonucleotides on an anion exchanger which is designed such that DNA begins to desorb from the anion exchanger only at an ionic strength corresponding to a sodium chloride solution of a concentration higher by at least 100 mM than one corre-sponding to the ionic strength at which RNA begins to desorb from the anion exchanger material.