03.27.23 -- Unveil The Potential Of Your AAV Gene Therapy

An essential part of the production of adeno-associated virus (AAV) vectors is the characterization of potential critical quality attributes (CQAs) using a range of analytical techniques. Learn about a set of novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

Empty adeno-associated virus (AAV) capsids have the potential to impact safety and efficacy, since they may stimulate an unwanted immune response without delivering the intended therapeutic benefit. Explore boundary data for a mixture of empty and filled AAV8 capsids and more from an internal study using AAV8 capsids.

The high sequence homology between different serotypes represents a challenge in establishing a specific test for confirming the identity of AAV products. View the results generated from a study where peptide mapping of two different AAV serotypes – AAV8 and AAV9 – was performed by LC-MS.

Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Next generation sequencing (NGS), also known as high-throughput sequencing, has emerged as a useful state-of-the-art method to establish product quality through sequence identity.

Viral clearance studies for non-enveloped viral vectors have been performed less frequently than those of enveloped viral vectors. For this reason, the virus inactivation steps and the model virus panel for clearance studies may not be as clear. Gain a better understanding of viral clearance studies for AAV vectors.