AAV characterization

Malvern Panalytical provides innovative biophysical solutions to address the complex challenges of AAV characterization. 

These tools empower researchers with the insights needed to optimize AAV formulation development, scale-up, and production, and ensure the delivery of safe and effective gene therapies.

Measuring particle size, charge, and concentration, The Zetasizer Advance Ultra delivers multidimensional insight into your AAV samples in a single, rapid experiment. 

The Zetasizer Ultra employs dynamic light scattering (DLS) and multi-angle dynamic light scattering (MADLS) technology to simultaneously measure the size and distribution of AAV particles, as well as well as the virus titer. It also employs electrophoretic light scattering (ELS) technology to determine the surface charge of AAV capsids and thus the colloidal stability of the solution. These insights help you analyze factors such as thermal stability, the likelihood of tissue penetration, and the risk of AAV aggregation in your formulation. 

Key Features and Benefits:

• Faster results, with up to three MADLS measurements in under 15 minutes.
• Higher resolution measurements thanks to MADLS technology.
• Maximum sample preservation due to non-destructive, label-free analysis and low sample volumes (starting at 3 µL).
• User-friendly software that enables automated workflows.
• Simplified regulatory compliance with the help of OmniTrust software (optional).
• Walk-away high throughput with our Sample Assistant to automate sample changing (optional).

With its ability to quickly deliver reliable, high-resolution data, the Zetasizer Advance Ultra is a critical asset for AAV formulation development and quality control.

OMNISEC uses multi-detection size exclusion chromatography (SEC) to provide a comprehensive analysis of AAV capsid titer, absolute molecular weight, aggregation, fragmentation, and full/empty capsid ratios. These factors are all crucial for understanding critical quality attributes of AAV formulations, such as the ideal dosage for your gene therapy.

Key Features and Benefits:

• Precise characterization of capsid titer and the ratio of full and empty capsids.
• Highly sensitive measurement of absolute molecular weight, aggregates, and oligomers.
• High-resolution analysis delivers precise characterization of viral heterogeneity.
• Advanced detection capabilities ensure reliable and reproducible results.
• Fully automated system setup enables an easy and intuitive workflow.

By delivering unparalleled insights into AAV quality attributes, OMNISEC supports researchers in optimizing production and meeting regulatory requirements.

The MicroCal PEAQ-DSC uses differential scanning calorimetry (DSC) to measure the thermal stability of biomolecules by subjecting samples to a controlled temperature increase.

The insights this generates into the thermal unfolding profiles of your samples are essential for optimizing the stability of AAV-based gene therapies, ensuring that they maintain their efficacy throughout early-stage development, storage condition and long-term stability of products.

Key Features and Benefits:

• Detailed insights into capsid stability and their higher order structure.
• Sensitive and reproducible analysis of thermal unfolding transitions of the AAV and their payload.
• Helps optimize formulations to improve AAV stability and shelf life.
• High-throughput capabilities help streamline workflows and accelerate development timelines.

The PEAQ-DSC is an essential tool for ensuring the robustness and stability of AAV-based therapies under various conditions.

Malvern Panalytical’s suite of biophysical instruments provides the technologies necessary to address the most critical aspects of AAV characterization. 

From determining capsid titer and size, to assessing stability and capsid integrity, our solutions empower vaccine and gene therapy developers to produce safe, effective, and high-quality medicines and vaccines to patients worldwide.