Quantify and Identify Adeno-Associated Virus Aggregates in Development, Formulation, and Quality Control

Quantify and Identify Adeno-Associated Virus Aggregates in Development, Formulation, and Quality Control

Brought to you by Waters | Wyatt Technology

Overview

Adeno-associated virus (AAV)-based gene therapies enable targeted delivery of genetic payloads are difficult to characterize due to limited supplies. As a result, critical quality attributes like subvisible particles—key to safety, efficacy, and regulatory approval—often get overlooked until it’s too late. This application note demonstrates how complete morphological analysis combined with fluorescence membrane microscopy (FMM) provides deep insight into serotype-specific aggregate formation and stability—using as little as 10 µL per sample.

Unlike differential scanning fluorimetry (DSF), which failed to predict aggregation trends, this approach accurately quantifies subvisible particles and membrane coverage under thermal, rotational, and freeze-thaw stress. By distinguishing proteinaceous aggregates, FMM offers a more reliable method for assessing AAV product quality and formulation stability, helping teams make better decisions on shelf life and efficacy throughout development.

Key Objectives

How to use the Aura system to detect and identify subvisible aggregates in 10 µL of AAV.
Why thermal stability metrics may not correlate with aggregate formation.
Discover stress-induced, serotype-specific aggregation behaviors.
How particle morphology and fluorescent membrane microscopy (FMM) helps you differentiate proteinaceous from non-protein aggregates.

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