Is the AAV Payload Impacting the Stability of Your Gene Therapy?

Adeno-associated viruses (AAVs) are the most commonly used viral vector for the targeted delivery of a therapeutic payload. It is important to monitor subvisible particle (SVPs) sources, a critical quality attribute (CQA), throughout the development process to develop control strategies. One source of SVP particle formation occurs when nucleic acids leak from the viral vector under common storage conditions. However, traditional SVP detection methods require milliliters of material to perform, which can be challenging for gene therapy developers since AAV material is expensive and time-consuming to produce. 

Aura+™ and Aura GT™ only require 5 µL of material to accurately ID, characterize, and quantify SVP particles, making it easy to detect whether DNA leakage is negatively impacting stability even in early development. Plus, you’ll know exactly which SVPs can be attributed to DNA leakage using Fluorescence Membrane Microscopy (FMM), a technology exclusive to Aura systems.