Researchers flagged viral-vector purification as an urgent gene-therapy bottleneck, arguing that current downstream processes struggle to reliably distinguish full, gene-loaded AAV capsids from empty particles. In particular, the field’s resin-based affinity approaches often fail to selectively capture full capsids, while low-flow processing increases cost and slows scale-up. Stefano Menegatti and colleagues at North Carolina State University highlighted how the purification workflow constraints can translate into delayed patient access and higher gene-therapy prices. Their assessment points to both product-quality selectivity and throughput as the core technical barriers. The report also described ongoing work supported by a NIIMBL grant, using AvXcel affinity adsorbents developed by ChromaGenix. Menegatti said preliminary data show full capsid fractions can rise from roughly 20–30% in raw AAV material to about 34–48% in the affinity eluate, outperforming industry benchmarks, while maintaining stability through repeated cleaning cycles. If improved capture of full capsids becomes scalable, it could reduce both batch-to-batch variability and downstream costs—two recurring constraints for broader commercialization of AAV therapies.
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