Description
SepFast DUO 8000 range is unique ion-exchange chromatography media utilising dual functionalities good for purifying large viruses, exosomes, or for removing DNA / RNA fragments (e.g.1 kb) after polymerisation reactions etc, if the pore size of SepFast DUO 7000 range isn’t big enough for certain large impurities. Individual beads are coated with an inert polymer out-layer giving a size-exclusion effect to >800KDa molecules to >5 million Dalton (depending on operational flow velocity). Inside the bead are anion-exchange or cation-exchange ligands.
The media can be packed in a column where viruses will pass through the column bed and collected in flow through fraction, whilst impurities will be captured within the beads. This affords a very gentle purification process resulting in efficient clean up and high recovery of active products.
The base matrix is a composite of polysaccharides that have been highly cross-linked. The media is stable in most of the chemical conditions experienced in bioprocessing industry. SepFast DUO 8000 can be used at process scale. Regulatory support files are available.
Pre-packed columns for screening and process development use are available at following sizes: 1 ml, 5 ml, 3.8 ml (7x100mm ID x BH), 9.5 ml (11x100mm ID x BH), 20 ml (16x100mm ID x BH), 53 ml (26x100mm ID x BH). All these columns have connections fully compatible to Akta systems. Column hardware has 6 bar (0.6 MPa) pressure rating. See Column Instruction for details of HiSep and Optio column hardware.
Pre-packed columns for pilot to production scale use with column diameter ranging from 5cm to 45cm are available on request. For bulk loose media, please contact us.
The range of SepFast DUO ion-exchange media is developed and supported for production scale chromatography use. Regulatory Support File (RSF) is available to assist process validation and submissions to regulatory authorities.