Manufacturing productivity will define the next era of AAV gene therapy
Cell & Gene Therapy Insights 2026; 12(10), 1007–1013
DOI: 10.18609/cgti.2026.127
AAV gene therapy has reached an inflection point. For much of the past decade, the field has focused heavily on capsid engineering to increase tissue tropism. These advances remain essential as more potent and better-targeted vectors can reduce the dose required per patient, potentially improving the safety and the feasibility of treating larger populations. However, as AAV therapies move beyond ultra-rare diseases and into indications with greater vector demand, the strategic bottleneck is shifting toward whether sufficient vector can be manufactured consistently and economically to make these therapies accessible. This Expert Insight argues that manufacturing productivity will become one of the primary determinants of long-term success in AAV gene therapy. Improvements in upstream yield, packaging efficiency, and manufacturability can influence manufacturing costs throughout development. As clinical trials progress, increased yield per batch can decrease inventory management complexity. While vector biology determines whether a therapy can work, manufacturing productivity increasingly determines whether it can reach patients at scale. The next wave of AAV innovation should treat productivity as a platform-defining attribute. Programs that integrate capsid performance, dose requirements, process productivity, and product quality early in development will be better positioned to support larger indications, reduce supply risk, and convert therapeutic promise into accessible medicines.