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Vironova BioAnalytics

Specialized for biopharmaceuticals

Your first choice of provider of transmission electron microscopy (TEM) analysis of vaccines, gene therapy and drug delivery particles such as viruses and liposomes.

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Worlds only GMP certified TEM analysis service provider

High-quality images acquired by our proprietary and FDA 21 CFR part 11 compliant software

Fast and trustworthy turnaround times enabling you an accurate and cost-effective bioprocess

Transmission electron microscopy and application experts within your domain

GMP certified

Transmission electron microscopy experts

What we do

Vironova BioAnalytics is a GMP-certified service provider of transmission electron microscopy (TEM) analysis. Vironova specializes in nanoparticle analysis with a specific focus on the characterization of components that are used for vaccines and gene-therapies. We have full GMP-certified analysis which could effectively address safety, efficacy, and stability of products.

Vironova BioAnalytics offers a complete TEM analysis package that includes both negative stain TEM (nsTEM) and cryogenic TEM (cryoTEM). Each analysis report provides useful morphological information that is translated into quantitative and qualitative data that aids in faster and informed decision.

Our workflow

When you choose Vironova AB to perform electron microscopy services for your products there is a small workflow of procedures to be followed. We will accompany you along the process and will do our best that your results are delivered as fast as it is possible.

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Our senior scientists can help you if you have scientific questions regarding your samples and analysis using TEM. When you decide to do the analysis at Vironova, we will initiate the project by preparing the necessary documents according to our procedures. Our “delivery team” will also guide you to ship your samples correctly. The analysis will be performed by our senior scientist and the analytical report will be finalized and send to you within 2 weeks after the project started.

Sample submission guide

 

Use our AAV Express services

Need to speed up your bioprocessing project timeline?

Our AAV Express service offers a guaranteed 4-business days turnaround time*, along with our signature expertise and quality.  

AAV Express for your project

*counting from first lab workday

Workflow AAV Express cropped

 

Validate your method of analysis (MoA)

We provide a possibility to validate your method of analysis through a validation study. Validating your method of analysis assures quality, reliability, and consistency of the result for the application of cryoTEM as an analytical procedure for a specific product.

Vironova has developed procedures referring to the ICH Q2 (R1) Guideline on Validation of Analytical Methods, to ensure that the method validation is ICH Q2 (R1) compliant.

Validate your method

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Receive a free quotation for your project

Our experts will tailor a quotation based on your specific project.

Request a free quote from us and one of our electron microscopy experts will contact you to start the discussion.

Request a quote

Our portfolio of analyses

Sample purity, particle size, shape and overall morphology are often directly correlated to the efficacy and safety of the end drug product. TEM is an unmatched technology for visualizing and understanding particle characteristics and seeing what happens when conditions are changed in upstream and downstream processes or product formulations.

There are a variety of nanoparticles that can be tested and analysed using TEM, at EM services we specialize in the following type of nanoparticles:

If you do not find your type of samples in the list above, please contact us. Our team of experts will suggest the type of TEM analysis suitable for your product.

Employee working with a sample in the Vironova EMS laboratory

Extensive service portfolio

Below you can find the common types of analyses (marked as red circle) provided by Vironova BioAnalytics, specific analyses can be provided upon requirement.

Note: Scroll the table sideways to see all information.

Viral vectors Type of analysis
  Overall morphology Size distribution Packaging Aggregation Circularity Integrity Customer-tailored particle classification Others
AAVs  
Adenoviral vectors  
Lentiviral vectors    
 Liposomes   Internal density assessment
 Lipid Nanoparticles (LNPs)   Lamellarity/Bilayer thickness
 Extracellular Vesicles (EVs) Internal volume and density assessment
 Virus-like Particles (VLPs)     Internal density assessment
Modified Vaccinia Ankara (MVA)      
Vesicular Stomatitis Virus (VSV)       Elongatedness
Bacteriophages     Tail attachment
Immune Stimulating Complexes (ISCOMs)            
Inorganic nanoparticles       Aspect ratio

 

Our GMP certified laboratory

Vironova has a GMP certificate of a manufacturer from the Swedish Medical Products Agency. Quoting the Swedish Medical Products Agency we are able to perform “Testing with the purpose of characterization, evaluation, quality assessment and quality control of particles in micro and nanometer scale (drug substances, intermediate drug substances, drug products) using negative stain TEM (nsTEM) and cryogenic TEM (cryoTEM) with semi-automatic particle detection and analysis using software”.

Learn more about our GMP certificate

Two people working in white lab coats in our GMP certified laboratory

An image from our GMP certified laboratory

Software designated for TEM image analysis

Our service team uses our proprietary Vironova Analyzer software (VAS) for the analysis of TEM images of nanoparticles. The software automates the extraction of morphological data and measurements from the TEM images for graphical presentation and statistical analysis. The automation that VAS provides allows Vironova EM services to deliver high-quality images and accurate quantitative data timely and cost-effectively.

Learn more about VAS

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Download and explore the example report

Reports are available for the following particles:

  • AAV
  • Adenovirus
  • Lentiviral vectors
  • Liposome
  • Doxorubicin liposome
  • Extracellular vesicles

FAQ about our BioAnalytics EM services

Mehedi-in-GMP-Lab-maintaiance

Do you have any questions?

Let our microscopist help you out!

If you have any further questions we encourage you to contact us so our microscopists can help you.

Contact us