GMP-certified software for TEM-based image analysis

FDA 21 CFR Part 11 compliant

VAS is a Vironova proprietary tool for computer-assisted analysis of transmission electron microscopy (TEM) images in a GMP-certified environment. It is suitable in biotechnology and life science environments requiring procedures and controls that ensure integrity, confidentiality, authenticity, and reliability in their electronic records in accordance with FDA 21 CFR part 11.

Controlled system access and user roles
Continuous import of acquired images
Data cannot be altered or deleted
All operations are logged in audit trails
Electronic signatures can be applied
Digitally signed analysis reports can be generated

VAS is used for all nanoparticle analysis services performed in Vironova's laboratory.
Our other tool VIAS is installed in our MiniTEM systems, read more here

Automation by machine learning

VAS has machine learning capabilities, making it possible to set up methods for automatic nanoparticle classification. The machine learning method, Support Vector Machines (SVM), is a supervised learning method. This means that the classifier must be trained on a set of manually classified particles before it can be applied to new, unclassified particles. To do this discrimination, it uses a predefined combination of features, including shape, size, and intensity profiles.

The trained classifier has proven capability of discriminating between filled, empty, and intermediate particles. It can be applied to all particles in an image or to individual particles.

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Time-saving

Significant time can be saved with VAS. This example shows the time required for manual analysis of liposome lamellarity in twenty images of an average quality sample. Using VAS instead of the manual imaging, detection, classification, and reporting can save your organization twelve hours per sample.

Validated AAV capsid packaging ratio analysis

Virus particle packaging analysis with cryoTEM in combination with VAS is a patented method by Vironova and the world's first validated method for full/empty/intermediate AAV capsid ratio analysis. This method is recommended for batch release testing and quality control of AAV-based gene therapy products.

AAV analysis in VAS-1
Representative cryoTEM images used for packaging analysis in VAS
Detected image (left) displaying the classified AAV particles overlaid with red, blue, and yellow circles. Principal component
analysis of each AAV particle’s radial density profile was performed using VAS and is displayed in the cluster plot (right).

Download and explore example reports

We have various example reports of different types of analyses available for you to download. The reports give you a deeper insight in what to expect from hiring our electron microscopy services.

The example reports are free and easily accessed by submitting a form. Just click the button below to get to the submission page.

VAS – Vironova Analyzer Software