AAV Analytics – Ultra-Low Volume AAV Aggregate Quantitation and Identification

Adeno-associated viruses (AAVs) have transformed gene therapies by enabling the targeted delivery of curative genetic payloads. As parenterally administered drugs, gene therapies must undergo the same rigorous safety testing required by the FDA for protein therapeutics. This includes characterizing the stability of the AAV vector by monitoring the formation of subvisible particles (SVPs) that can also lead to adverse immunogenic events. However, the amount of AAV material available is limited as it is expensive, time-consuming, and labor-intensive to produce.

The Aura™ platform is the first ultra-low volume, subvisible particle analysis system that quantitates and identifies AAV aggregates with as little as 5 µL, for significant precious sample savings compared to flow imaging methods.

Subvisible Particle Counts Are an Indicator of AAV Stability

Subvisible particle measurements are a stability predictor that minimizes risk and enables more informed decisions about viral vector formulations and quality assessment. Backgrounded Membrane Imaging (BMI) on the Aura system detects how parameters like freeze-thaw cycles, ionic strength, and different additives influence AAV vector stability to determine optimal formulation and storage conditions for your gene therapy product.

AAV vector stability under different ionic strength conditions

Effects of ionic strength on insoluble aggregate formation in AAV samples. Higher particle counts are detected with increased stress.

AAV vector stability after multiple rounds of freeze-thaw

Effects of freeze-thaw cycles on insoluble aggregate formation in AAV samples. Higher particle counts are detected with increased stress.

AAV vector stability after the additional of different additives

Effects of different additives on insoluble aggregation formation in AAV samples after stress.