Guidelines

CIMmultus® EV columns are designed for high selectivity exosome purification and removal of host cell DNA, viruses, and non-exosome vesicles. The protocols described are applicable for bench-scale purification and can be easily scaled up to industrial manufacturing. The advantage of monolithic columns allows high flow rates with low shear environment and short processing times. You can purify exosomes with CIMmultus® EV columns from a wide variety of source materials. The accepted procedure will depend on the impurity profile of your sample.

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.