Streamline AAV-Based Gene Therapies with High-Performing Off-the-Shelf Plasmids
Abstract: AAV gene therapy programs face long development cycles, raw material variability, and complex scale-up demands. This white paper explains how optimized off-the-shelf plasmids strengthen early and late development by improving consistency, accelerating timelines, and simplifying supply chains. Catalent’s UpTempo AAV platform combines standardized pHelper and Rep/Cap plasmids, a clonal HEK293 cell line, pre-qualified analytics, and platform documentation to shorten development from 18–20 months to as little as nine months. The paper outlines how well-characterized plasmids support higher reproducibility, better manufacturability, and smoother regulatory pathways across common and emerging AAV serotypes. It also shows how integrated plasmid, process, and analytical expertise help developers advance from preclinical work to cGMP production with greater confidence and control.