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Achieving consistent, high-quality EVs requires meticulous monitoring throughout the manufacturing process. Our GMP-certified TEM analysis offers valuable insights into the stability, integrity, and purity of your EVs. From identifying product clusters/aggregates to detecting any failure in removing host cell debris, our unbiased AI-based analysis offers you an extra layer of quality assurance.


Quality Control Reinvented: Monitoring Manufacturing Processes with TEM

We employ Cryogenic Transmission Electron Microscopy (cryoTEM), one of the most powerful analytical tools, to characterize the properties of your EVs. Our AI-based software, VAS, helps in identifying distinct morphological features in different exosomes, providing you with crucial insights to guide your research and product development.

EVs cryoTEM

Discover the intriguing realm of exosomes with our representative Cryogenic Transmission Electron Microscopy (cryoTEM) images. The left column features engineered exosomes, exhibiting a variety of sizes and morphologies. Notice the particles with dark internal density, alongside multilamellar and multiparticle types. On the right, purified exosomes from the serum of healthy donors display a higher level of pleomorphism compared to the engineered ones. Harness the power of our proprietary software, VAS, to define the particle classes present in your product and provide statistical data that can correlate with the biological significance of the product. 

Quality Control Measures: Circularity and Size Distribution

We ensure that the unique characteristics of your EVs are preserved during the analysis process. Our cryo-TEM sample preparation procedure enables reliable measurements of the size and circularity of exosomes, providing you with a comprehensive profile of your EVs' loading capacity.

LNPs size and circularity 1

Unveil a comprehensive view of your exosome samples with our representative histogram. This figure showcases the size distribution (left) and circularity distribution (right) of exosomes as determined by our semi-automated, AI-powered detection system. By providing a clear snapshot of the heterogeneity of your sample, we empower you with valuable insights to optimize your product formulation and manufacturing processes.

Purity and Stability: The nsTEM Advantage

Our Negative Stain Transmission Electron Microscopy (nsTEM) technique boosts image contrast, giving you a clear picture of your exosomes' size distribution. It also aids in assessing the purity and integrity of your samples, providing critical quality control information that can be used to enhance your product's quality.


Discover the integrity of your exosome samples with our Negative Stain Transmission Electron Microscopy (nsTEM) imaging technique. This image presents representative nsTEM visuals of exosome samples, clearly displaying instances of broken particles and aggregates. These high-contrast images offer a critical evaluation of your sample's quality, highlighting potential issues with sample integrity. With nsTEM, we provide you with crucial insights to enhance your product's quality and drive your research forward.

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What is the optimal concentration of exosomes required for TEM analysis?
We recommend a concentration of 5x1,011 particles/mL, as determined by Nanoparticle Tracking Analysis. This concentration typically renders 3 to 4 EVs per image in cryoTEM imaging. Interestingly, you can expect a higher number of particles per image when the same sample is prepared for nsTEM. We understand that every product is unique, and we're always prepared to optimize the sample preparation procedure to enhance the on-grid concentration for your specific product.

Does Vironova perform GMP-certified analysis on exosome samples?
Yes, Vironova can perform GMP-certified analysis on exosomes.

Can the purity of exosome samples be tracked between different purification steps?
Our TEM analysis allows you to track the purity of your exosome samples between different purification steps. 

What level of biosafety is available for sample analysis at Vironova?
Our GMP-certified laboratory in Stockholm is equipped to perform TEM analysis on samples up to biosafety level 2.


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