This article from The Medicine Maker examines current approaches to enhancing AAV vector manufacturing, with a focus on improving consistency, analytical standards, and regulatory alignment to support the development of high-quality gene therapies.
In this expert opinion piece, Efrain Guzman explores how the longstanding triple plasmid transfection method is holding back AAV manufacturing quality and how emerging technologies are changing that. With gene therapy’s growing potential, he argues it's time to move beyond legacy production models that introduce inconsistencies and impurities into AAV drug products.
By leveraging next-generation sequencing and advanced analytics, manufacturers can now identify and minimize contaminating DNA in viral vectors, improving both safety and therapeutic efficacy. Guzman outlines how innovations in quality control and genome integrity analysis are paving the way for a new era of high-quality, scalable AAV manufacturing.
