Genome length
Ensuring the highest product quality at every stage of development and across the product lifecycle is key for the safety and potency of medicinal products. A cornerstone of this process is robust characterization analysis, which provides precise and accurate data about critical quality attributes throughout product development.
For AAV products, one major challenge lies in identifying the presence of full, empty, or partially filled capsids. These capsids, along with their genome,
capsid proteins, transgene components, and potential impurities such as encapsulated host cell or plasmid DNA, can contribute to immunogenic responses. Advanced image analysis of cryoTEM data offers a powerful solution, enabling detailed characterization of vector content and ensuring the integrity and safety of AAV particles.
This approach ensures that AAV-based therapies meet the highest quality standards, supporting their growing role in gene therapy and other innovative treatments.
3rd generation method
Genome length determination
The method was developed with the intention to create an automatic, robust, and objective method for AAV analysis; a future-proof method from which absolute density values can be determined and used to unambiguously classify all capsid subpopulations and their genome lengths.
internal density gradient
Validated platform
The platform was validated in 2024 and offers unique insights into transgene incorporation by translating intricate visual details from TEM images into vector content (%Filled, %Partially Filled, %Empty) and genome length of each capsid subpopulation.
Examples
The principle of the genome length determination method can be applied to any VLPs that contains a non protein bound genome.
Example reports
Download an example report that includes:
- Determine subpopulations (e.g. empty, partially filled, filled) exist in the sample
- Determine genome length of AAVs
