Gene therapy is progressing quickly, but persistent manufacturing challenges still restrict its accessibility to reach patients in need. This article outlines how these barriers can be addressed by implementing more efficient, scalable production platforms. To overcome production limitations, advanced manufacturing systems can provide an integrated approach designed to improve efficiency, consistency, and scalability. The case study in this article illustrates how an advanced platform supports robust AAV5 production in adherent cells, presenting comparative data across three fixed-bed bioreactor scales. The results demonstrate a complete and practical scaling strategy from benchtop to large-scale manufacturing, highlighting the potential of advanced bioreactor systems to streamline gene therapy production and expand patient access.
Krekels et al. (Mon,) studied this question.