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Genome length

The ability to ensure the highest product quality across all stages of product development and the product life cycle is key to ensuring the safety and efficacy of medicinal products, and to minimizing potential adverse events. One crucial element to this, is having robust characterization analyses that provide precise and accurate data about critical quality attributes throughout product development.

For AAV products, the presence of full, empty, and partially filled capsids are a significant factor to be considered as the genome, capsid, transgene component, potential encapsulated host cell, and plasmid DNA impurities are the main components that can cause an immunogenic response. Today, there are several techniques employed by the industry to characterize and monitor these capsid populations, one of which is cryogenic Transmission Electron Microscopy (cryoTEM).

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.

Genome length for web_1
AAV intermediate full empty_genome length

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.

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AAV analysis

generation 3 method

 

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