New Targets in the Spotlight: AAVs, VLPs and pDNA

In the world of biotechnology and pharmaceutical industry, the effective and reliable purification of complex biomolecules used for gene therapy is of crucial importance. In particular, the isolation of adeno-associated viruses (AAVs), virus-like particles (VLPs), and also plasmid DNA (pDNA) places high demands on the chromatography technologies used. As the demand for gene therapies grows, so does the need for highly specialised solutions which provide the precise purification of native and intact molecules ensuring the safety and efficacy of such therapeutics.

Macro-porous IEX Resin – The New Standard in Viral Vector and pDNA Purification

Purifying large biomolecules presents distinct challenges. Standard chromatography resins, optimised for proteins, antibodies, and oligonucleotides, often fall short when it comes to viral vectors and plasmid DNA.
Limited pore accessibility and suboptimal binding capacity restrict performance, while the structural similarity of impurities further complicates separation. Macro-porous ion-exchange (IEX) resins provide a breakthrough solution.

Their enlarged pore structure enhances accessibility, maximising surface interaction and boosting binding capacity. YMC’s MacroSep IEX Q resin is engineered for these demanding applications, delivering exceptional separation efficiency—even at high flow rates. The result: optimised purification of AAVs, VLPs, and pDNA, enabling higher productivity and process performance.

Focus on Viral Vectors: High Resolution Purification of AAVs

AAVs play a central role in gene therapy as they are one of the major vectors in this field. The separation of full capsids which are the effective ones from the empty vectors without any genetic payload is a particular challenge.
Both have similar physical properties and sizes and therefore require high resolution resins for their purification. The innovative MacroSep IEX Qresin is the ideal choice for this purification task. In a real-life application, the anion exchange resin increased the purity of full AAV2 from 54.4% up to 91.2% in a single step. This significant improvement in purity is due to the high resolution and excellent separation performance of the macro-porous structure of the resin. MacroSep IEX Q provides consistent and reproducible results as there are no carry-over effects. This enables a high level of process reliability and allows reproducible operation especially in cGMP production.

Essential for Gene Therapy: High Purity Plasmid DNA in Large Amounts

For viral vector manufacturing as described above, the development of plasmid DNA is crucial. During its purification, it is essential to separate the correctly folded supercoiled (Sc) DNA from its structural variants – the linear (L) and open circular (Oc) forms, which are highly similar but lack functionality. With MacroSep IEX Q, the supercoiled pDNA can be separated from the non-functional species with the highest purity, resulting in a significant increase in productivity and purity. Due to the particle size of 30 µm outstanding resolution, even for demanding separation tasks can be achieved. This makes it the ideal choice for polishing steps. Furthermore, it reduces the complexity of many purification processes as its high binding capacity makes it perfectly suited for capturing processes – even for large pDNA. It therefore opens up the possibility for a one-step purification streamlining the purification and improving overall process costs.

In More Detail: Resin Properties

MacroSep IEX Q has improved pressure-flow characteristics that result in higher productivity. The resin’s hydrophilic polymer beads allow increased flow rates with excellent resolution. In addition, it offers a high dynamic binding capacity (DBC) for large biomolecules and complexes. Compared to other resins, MacroSep IEX Q shows up to 30% higher DBC, resulting in an increased productivity. Another important advantage is the high stability during cleaning in place (CIP) procedures that are crucial in the field of gene therapeutic manufacturing. MacroSep IEX Q is fully compatible with 1 M NaOH CIP protocols and maintains a constant dynamic binding capacity even after 200 CIP cycles.
This ensures long column life and continuous high performance. The combination of high DBC, excellent resolution and robust CIP stability makes MacroSep IEX Q the new standard for modern bioprocesses.

Short and Sweet

With MacroSep IEX Q, YMC offers an innovative solution that meets the high demands of modern biotechnology. The product combines high productivity with maximum reproducibility and enables even demanding purification processes to be carried out efficiently and reliably.

Experience the benefits of MacroSep IEX Q and optimise your bioprocesses with the leading anion exchange resin for large biomolecules.