From bottleneck to breakthrough: how downstream process innovation, analytics, and AI are reshaping AAV‑based gene therapy

“Looking ahead, 2026 appears poised to be a highly transformative year for AAV from a regulatory perspective.”

AAV purification is increasingly in the spotlight, with the separation and characterization of empty, full, and partially full capsids becoming a particularly important focal point for industry and regulators alike. Meanwhile, process and analytical tools innovation is helping to accelerate decision‑making, support improvements in vector product quality, and broaden the horizons of a gene therapy sector looking to rebound from a testing past few years.

Scott Jeffers (Chief Technology Officer, GenSight Biologics), Samarendra Mohanty (President, and Chief Scientific Officer, Nanoscope Therapeutics), Jayan Senaratne (Director of Downstream Process Development, MeiraGTx), Andrew D Tustian (Executive Director, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals), and Pouria Motevalian (Process Development Director at Thermo Fisher Scientific) join Cell & Gene Therapy Insights to analyze the key purification challenges and opportunities facing gene therapy developers and manufacturers, and share their advice on how to make use of a rapidly evolving manufacturing toolkit.

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