Abstract
Recent developments in gene therapy have increased the need for the large-scale production of pharmaceutical-grade plasmid DNA. Regulatory agencies require final preparations to be free of host RNA, genomic DNA, proteins and lipopolysaccharides. This paper reports the application of anion-exchange high-performance liquid chromatography (HPLC) to the analysis of process streams during the downstream processing of plasmid DNA for gene therapy. An HPLC purity degree and a purification factor were defined and used to demostrate that process ion-exchange largely reduces the amount of impurities (purification factor of 70.1). However, since plasmid purity after ion-exchange was 59.3% a further gel-filtration step was included in order to reach 100% purity.
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