Adeno Associated Viral Vector Characterisation

Benefit from our unique, high-throughput cryo-EM platform, and discern challenging epitopes in 3D.

AAV Full-Emptry-Intermediate characterization

Cryo-electron microscopy (cryo-EM) stands as the sole imaging method offering single-particle precision in pharmaceutical R&D for gene therapy. ATEM leverages proprietary software to enhance adeno-associated virus (AAV) characterization, a key vector in gene delivery.

ATEM’s cryo-EM technology boasts sample efficiency, requiring only 50 μl of sample at 10^12 particles, far less than the 500 μl at 10^13 particles needed by Analytical Ultracentrifugation, the existing gold standard.

This efficiency does not detract from the technology’s capacity to deliver detailed and validated analyses of AAV critical quality attributes (CQAs), distinguishing between full, empty, and intermediate AAV particles—a capability often lacking in traditional methods. This precision is crucial for gene delivery, as full particles contain the therapeutic genetic material.

ATEM’s software tools are in the process of gaining GMP certification, reinforcing their reliability and robustness. The cryo-EM technology also reveals other CQAs like particle aggregation and capsid integrity, enabling comprehensive, high-resolution characterization vital for ensuring batch consistency, refining production processes, and enhancing the safety and efficacy of gene therapies. Thus, ATEM’s cryo-EM, with its detailed, validated, and sample-efficient quantitative analysis, is poised to significantly influence gene therapy advancements in pharmaceutical R&D.

Proprietary AAV full/empty/intermediate characterization
Low sample requirements of 50 μl at 10^12 particle titer
Soon to be GMP validated
Benefits of cryo-EM AAV Characterisation Single particle precision characterisation Minimal sample requirements Characterize full, empty and intermediate particle classes & histogram profile Highest statistical precision & accuracy
Applications Characterize capsid quality & gene encapsulation integrity Verify & benchmark consistency in scale-up Extended characterization for GMP batch release Influence gene therapy advancements in pharmaceutical R&D

Leverage highest precision analytical cryo-EM to characterize your AAVs

AAV Characterization process

Offering a simple process and fast turnaround times
01

Sample delivery

Delivery of 50 μl at least 10^12 tider in 2 seperate vials. Individial needs can be discussed bilaterally
02

Data acquisition

We apply our standardized highly robust processes for cryo-grid preparation and high magnification image acquisition
03

Data analysis

The image data is analyzed with validated proprietary software, fully automated analysis of fill rate and particle integrity
04

Report

We deliver a comprehensive report analyzing >5.000 capsid ensuring highest statistical significance

Sample requirements

Sample amount: 50 μl at 5x 10^12 particles/ml tider
Sample delivered in 2 vials on dry ice

We prepare everything else. We receive your sample, then optimise and test it before returning the data in a personalised way to meet your needs.

Sample amounts
CONTENT REQUIRED
Turnaround times
Results are delivered from the date of sample arrivale within 20 days
Results
Providing comprehensive quantitative report of request CQAs e.g. Capsid Fill Rate