Innovative Anion Exchange Resin for Purification of Large Biomolecules

The development of new therapeutic strategies such as gene therapy also has consequences for DSP. Established strategies must be redesigned and the selection of resins for purification in particular must be optimised accordingly. The targets are becoming ever larger, meaning that resins with standard pore sizes, which are optimised for small and medium-sized biomolecules, do not enable efficient binding of large molecules. This is because the small pores are not accessible to macromolecules, which has a massive impact on their binding and separation. Therefore, YMC has developed a new and innovative IEX resin that targets these biomolecules and particles such as adeno-associated viruses (AAVs), protein complexes and plasmid DNA (pDNA): MacroSep IEX Q!

Case Study: Highly Efficient Purification of AAV2

AAVs have become one of the main vectors of gene therapies. So, an efficient and safe purification is needed that removes the non-functional particles without the genetic payload (empty) from the correct ones containing the genetic material required for their function (full). In a real-life example, a purification process for full AAV2 was developed. The AEX purification step with MacroSep IEX Q has increased the purity level of the target immensely. Starting from a purity of 54.4% in the feed solution, the final purity after purification was 91.2%. Therefore, MacroSep IEX Q is the ideal resin for purification of AAV with high resolution! 

Purification of Plasmid-DNA (pDNA)

Plasmid DNA (pDNA) is crucial for the production of recombinant proteins and gene therapeutics. The separation of the supercoiled (Sc) pDNA from the non-functional species – the linearised (L) and nicked open-circular (Oc) form – is the major challenge during the production and purification process of these complex molecules. All species are highly similar therefore high-resolution separation at reasonable throughput is needed.

The application shows: with MacroSep IEX Q the two highly similar pDNA species – open-circular and super-coiled – can be separated with high resolution. This leads to a highly efficient purification process resulting in a highly pure product. The blank run verifies that no carry-over effects can be observed.

At a glance: Superior Characteristics of MacroSep IEX Q

• Ion exchange media based on hydrophilic polymethacrylate beads
• Optimised macro-porous structure for the separation of large-sized biomolecules
• Strong anion exchanger providing high dynamic binding capacity (DBC)
• Ideal particle size (30 µm) for efficient purifications at improved resolution – even at increased flow rates
• Long lifetime for increased productivity

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