Gene therapies, including AAV-based systems, have shown great promise in clinical trials, offering hope for treating a variety of genetic disorders. The efficacy of these therapies depends, among many factors, on the ratio of full to empty vectors, a critical quality attribute which can be clearly evaluated using Transmission Electron Microscopy (TEM).
QuTEM has TEM methods which resolve fully filled, partially filled, and empty vectors, which is crucial information for understanding treatment efficacy and immunogenicity. Compared to orthogonal methods, TEM analysis is relatively unaffected by the presence of proteins, debris, and aggregation, allowing for accurate particle classification and ratio calculations.
QuTEM’s TEM vector content analysis based on particle internal density provides full/empty ratio for a variety of vector types.
QuTEM's method was developed to provide an automated, robust, and objective approach for vector content analysis.
At QuTEM, vector content analysis is typically conducted for the following types of particles.
Our method is an automatic and robust method which provides objective data on vector ratio and vector content. Our analysis workflow includes: