Aug 19, 2026 —
Inefficiencies that limit the global supply of viral vectors are holding back the gene therapy industry, according to researchers who point to an urgent need for better downstream purification materials.
Adeno-associated viruses (AAVs) are the leading delivery vehicles for gene therapies, but producing them at the purity, potency, and scale required for clinical use remains a major challenge, said Stefano Menegatti, PhD, a professor of chemical and biomolecular engineering at North Carolina State University. A central obstacle, he noted, is that current purification materials — typically resin-based affinity adsorbents — cannot distinguish full AAV capsids, which carry the therapeutic genetic payload, from empty capsids that do not.
Current purification technologies also operate at slow flow rates and can require harsh conditions that damage the product, driving up manufacturing time and cost — factors that ultimately translate into delayed patient access and higher prices. To address this, Menegatti and colleague Michael Daniele, PhD, received a NIIMBL grant to develop purification materials that can differentiate full from empty capsids. In preliminary work, the researchers reported increasing the fraction of full capsids from roughly 20–30% in the raw material to 34–48% at the capture step.
The work underscores how advances in downstream processing and analytics are central to making AAV gene therapies more scalable, affordable, and accessible.
