Guidelines

HiP2 Plasmid Process Pack™ produces low endotoxin, highly homogeneous supercoiled plasmid DNA (pDNA) of clinical grade. The process is applicable for bench scale purification and can be scaled up for manufacturing of pDNA as raw material or drug substance. The advantage of monolithic columns allows high flow rates and short processing times.

Contaminants are removed without the use of enzymatic treatment. Potassium acetate and calcium chloride precipitation alongside two separate chromatography steps are used for removal of RNA, endotoxin, genomic DNA, protein and other contaminants. The first chromatography step separates contaminant RNA and proteins from the plasmid DNA. The polishing step eliminates remains of genomic DNA, endotoxin and open circular (oc) and linear pDNA isoforms, resulting in the isolation of the supercoiled (sc) pDNA isoform.