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AAV-based gene therapies have shown great promise in clinical trials, offering hope for treating a variety of genetic disorders with remarkable precision and efficacy. The efficacy of these therapies depends on the ratio of full to empty capsids, a critical quality attribute which can be clearly evaluated using Transmission Electron Microscopy (TEM). 

By visualizing each AAV particle, TEM can differentiate between fully filled, partially filled, and empty particles, 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.  

GMP-LAB-2023

3rd generation method

Genome length determination

QuTEM’s TEM analysis extends to determine the genome length of individual particles, enhancing our understanding of AAV-based therapies and assuring their potency and safety in clinical use. 

Analyses

At QuTEM, we generally offer the following analyses for AAV particles.

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Aggregation

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Membrane thickness

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Lamellarity

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Lamellarity

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Aggregation

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Membrane thickness

Unique, market leading analysis

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GMP-LAB-2023
AAV cryo_1

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1500

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185

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M+

2M+

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35

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Frequently asked questions

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Further reading

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Ready for analyses?

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