AAV Aggregation Analysis And Low Volume Characterization

Through innovative technology that enables particle quantitation and identification in as little as 5 µL of material, you can quickly obtain the critical AAV aggregation data you need to evaluate stability and ensure the development and manufacturing of a safe gene therapy.

Overcome a bottleneck in gene therapy development and manufacturing

We tested an AAV2 vector for aggregation under a variety of stress conditions—(a) the concentration of particles with an equivalent circular diameter (ECD) ≥ 2 μm and (b) the percentage of the membrane covered by particles.

Why Use Aura Systems for AAV Analytics?

Because you can achieve so much more insight with much less material:
  • Detect and characterize particles not measured by dynamic light scattering (DLS) or size exclusion chromatography (SEC)
  • Preserve sample, using as little as 5 μL per test
  • Quickly screen a wide range of conditions with our 96-well format
  • Obtain detailed information on particles that other methods can’t deliver, including size, morphology, count, and size distribution
  • Move quickly with an analysis time of about 1 minute per sample
  • Evaluate a wide range of particle sizes, measuring 1 μm to 5 mm with high reproducibility
  • Achieve high sensitivity because particles are imaged without the interference of buffer or matrix
  • See more detail for better particle identification with high-resolution magnification
  • Maintain compliance with the option for 21 CFR Part 11 software

Compare Stability of AAV Serotypes Under Thermal Stress

Using the Aura GT system, we observed low levels of SVPs in stock AAV2 samples. Well-defined, small to large granular particles are formed after thermal stress.

We observed increased levels of SVPs in stock AAV5 samples compared to stock AAV2 samples. Large fibrillar structures are formed after thermal stress.

We observed increased levels of SVPs in stock AAV8 samples compared to stock AAV2 and AAV5 samples. Complete sample degradation was observed as the stressed AAV8 sample denatured into a film-like matrix.

Particle Vue software can provide a quantitative analysis of the different AAV serotypes with and without thermal stress by measuring the concentration of particles > 2 µm.

Definitively Confirm Detected SVPs are Aggregated Capsid