ViroTEM

TEM based analysis system for viral vectors and vaccine development

A powerful, semi-automated and versatile system for analysis and characterization of nanoparticles, viral-based biotherapeutics and other applications in biotherapeutic development and production.

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An in-house solution for TEM analysis. for direct analysis of product quality during manufacturing.

Intuitive systems with automation with powerful AI analysis for non-expert users.

Rapid method suitable for routine daily analysis. Only small volume of product needed.

One method answers many questions about the product. Reducing risk, saving time, and money.

Offers an in-house solution for TEM analysis. for direct analysis of product quality during manufacturing.

Intuitive systems with automation for non-expert users with powerful AI analysis.

Access the power and intelligence of transmission electron microscopy

ViroTEM offers a powerful and in-house analytical solution enabling experts and non-experts in electron microscopy within the biopharmaceutical industry to rapidly obtain meaningful nanoparticle characterization data and insights.

The system is powered by our software VIAS which automatically images, detects and analyzes particles with defined morphological characteristics. It further transforms the data into accurate metrics which will help you to get meaningful insights.

ViroTEM delivers:

  • Rapid and efficient specimen searching (full grid overview) and high-resolution image acquisition enabled by a dual-camera system.
  • High-sample throughput via a “one touch” three specimen holder.
  • Broad range of applications made possible by the wide accelerating voltage range (20-120 kV).

Saba Husein-Gore-ViroTEM-at-Vironova-Lab-Stockholm-HQ

 

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With ViroTEM, your organization can make faster and more better-informed decisions and get a more reliable final product.

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Sytem overview

The ViroTEM analysis system comprises:

1. A 120 kV transmission electron microscope (TEM) with multiple lens configurations, including a standard lens for unsurpassed high contrast and a class-leading HR lens for high resolution. This innovative design allows for a wide variety of specialized applications.

2. Vironova Imaging and Analysis Software (VIAS) which provides semi-automatic image acquisition as well as subsequent analysis and data presentation. Pattern recognition and machine learning capabilities enable VIAS to perform advanced particle characterization, classification and measurements.

The combination of the advanced TEM-system together with VIAS software enables automated 2-level screening which allows the system to determine which grid squares are suitable for imaging and then acquires a series of high-resolution images at a pre-determined number of locations on the grid.

The ViroTEM system with Vironova's and ViroTEM's logotypes

Figure 1 - The ViroTEM system is a versatile TEM-based analysis systen designed for simple operation but with powerful functionality.

Main applications

The performance and versatility of the ViroTEM system enables a large range of applications.

  • Determine particle size distributions of viral vectors and sample components.
  • Verify sample purity to verify downstream process capabilities and/or batch-to-batch variation.
  • Assess particle integrity when making changes in process conditions, including formulation buffers.
  • Visualize sample morphology to extract structural information about the sample.
  • Identify sample contaminants such as viruses (e.g. in cell bank characterization) or bacteriophage (e.g. in investigations of fermenter contaminations).

Semi-automated multilevel screening

The semi-automated, multilevel screening functionality of the ViroTEM involves four main steps:

Step 1

Acquire grid-square images at large field-of-view. The system automatically adjusts to grid orientation.

Step 2

The system compares each image to reference image(s) to assess suitability for imaging.

Step 3

High-resolution images are obtained from grid squares that have been given a high suitability rating.

Step 4

Images are analyzed to identify (i.e. segment) and classify particles.

Reliable data analysis

The ViroTEM system translates TEM image data into quantitative analytics which can be used to make informed decisions in process development and manufacturing. Figure 3 shows an example of an analysis performed on adeno-associated viruses (AAVs).

HT7800-Figure_3-Example_analysis

Figure 3 - Analysis of internally-stained versus non-stained AAVs. Internally-stained vectors can be correlated to a loss of vector-integrity.

Secure data storage

The ViroTEM analysis systems stores data in a secure SQL database structure. The database can be located locally on the control PC, or can be installed in a network environment.

Summary

To make good decisions in the manufacturing of gene therapy and vaccine vectors, scientists need high-quality analytical information, immediately. Transmission electron microscopy (TEM) enables direct visualization of viral vectors and their assessment by a comprehensive morphological characterization. Using our intuitive ViroTEM for the analysis of viral vectors allows monitoring product contamination, purity and morphology in-house by non-experts rapidly, saving time, money, and delivering a safer and better characterized final product.

The ViroTEM analysis system is a powerful 120 kW tool for biotherapeutic application methods, especially those involving viral structures, including:

  • Gene therapy
  • Cell therapy
  • Viral-based vaccines
  • Virus and bacteriophage contaminations

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Our TEM experts are here to help you out.

If you have questions regarding ViroTEM or any other product or service in our portfolio, you are more than welcome to contact us.

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