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15 of our clients most frequent asked questions (FAQ)

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1. What type of services do Vironova BioAnalytics provide?

Vironova provides fast and cost-effective GMP-certified electron microscopy services enabled with our own proprietary software. Our services are performed in the world’s only GMP-certified TEM laboratory. this makes us the only company with a full-service value chain offer from start to finish.

Vironova is the leading partner for the biopharma and life science industry with over 200 established customer relationships. By combining deep industry expertise and data-driven insights, we help our clients solve their needs by making the subvisible accessible.

We offer a complete transmission electron microscopy (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 to make  rapid informed decision.

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cryoTEM images of various viral vector particles.
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nsTEM images of various viral vector particles.

2. What can be analyzed with TEM?

At Vironova BioAnalytics, we offer expertise in nanoparticle characterization in the fields of gene therapy, vaccines, and drug delivery. Direct imaging of viral vectors, for instance, is extremely useful for distinguishing the morphological features within a sample to answer not just one, but several critical questions, such as:

  • Have all the host cell debris been removed during the downstream purification process? (e.g., purification-inefficient packing causes empty capsid impurities?
  • Has the particle morphology or integrity degraded due to unsuitable downstream conditions?
  • Have product aggregates formed during upstream operations or due to unsuitable downstream conditions?
  • How many particles with different morphologies are present in the sample, and what is the particle percentage of each type of particle?

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Manufacturing process of viral vectors.

3. Which nanoparticles can you test and analyze using your TEM services?

At Vironova BioAnalytics we specialize in the following type of nanoparticles:

  • AAV vectors
  • Adenovirus vectors
  • Lentiviral vectors
  • Liposomes and drug delivery systems
  • Extracellular vesicles
  • Others

If you do not find your type of sample in the list above, please feel free to contact us via email on our web. Our team of experts will suggest the type of TEM analysis suitable for your product within one business day.

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A visualization of our portfolio of analyzes by technique and analysis method.

4. What are the different steps in the process when you start an service project with you?

It’s very simple and has five step process. 

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Vironova BioAnalytics workflow

5. How does Vironova perform image analysis?

All the image analyses provided by our services are performed using our proprietary software Vironova analyzer software (VAS). VAS was specifically developed to answer the needs of using TEM as an analytical tool for nanoparticle characterization. The software is one of a kind in its class which is FDA 21 CFR Part 11 compliant and GMP certified.

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TEM images of viral vectors.

6. How many days will it normally take for my sample to be analyzed?

Your project will be performed during the reserved time slot. Images and the report will be sent within 10 working days after the project started. You will receive the following from our services:

  • Performed in the world’s only GMP-certified TEM laboratory.
  • Images and analyses made with our proprietary FDA 21 CFR Part 11 compliant software.
  • Accurate, traceable, and consistent results.
  • All analysis data collected in one comprehensive report.

7. I need my samples to be analyzed faster and your services faster to determine the next steps in my bioprocessing process? is it possible?

For AAV analyses, we offer an AAV Express service guaranteeing a delivery time of 4 working days from the date of we receive your sample. You will receive the following from our services:

  • Performed in the world’s only GMP-certified TEM laboratory.
  • Images and analyses made with our proprietary FDA 21 CFR Part 11 compliant software.
  • Accurate, traceable, and consistent results.
  • All analysis data collected in one comprehensive report.

8. What does it mean that you have a GMP certified TEM laboratory?

Vironova has a Good Manufacturing Practice (GMP) certificate as 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”.

You can learn more about our GMP certificate here.

9. Although Vironova is a specialist in GMP-certified analysis, is it possible to perform a non-GMP analysis?

Yes, of course we provide non-GMP analysis in cases where there is no requirement for GMP compliance.

10. Can you validate our method of analysis (MoA) through a validation study?

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

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

11. What is the required volume and particle concentration of the sample, in order to perform the TEM analysis?

We require a minimum volume of 25 µL of sample and 2 mL of buffer, in case dilutions are needed. The sample concentration is dependent on different factors, particularly sample composition. As an example, adeno associated virus (AAV) vectors sample requires a concentration range between 1012-1013 viral particles per mL for TEM analysis. For more information on other type of samples please click here.

12. Why is it not possible for Vironova to use my buffer from one project to another, or even the same vial for different types of analyses?

Since we are a GMP facility we have standard operating procedures that ensure good sample traceability. To avoid cross-contamination we do not use the buffer from one project to another. For the same reason, we also do not recommend the use of the same sample vial for two different projects.

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13. Why is it so important that the sample submission form (SSF) is shipped together with our sample?

The sample submission form (SSF) document shows the unique project number for your project and can be traced back to the unique sample name. For this reason, it is of extreme importance that our team receives the SSF together with the sample. This ensures traceability between the sample shipment and the project.

14. What are the technical differences between nsTEM and cryoTEM for AAV analysis?

In both techniques, 3 µL of the specimen is typically deposited on a copper grid coated with a hydrophilized carbon film, which serves as a support for the sample. The excess sample is then blotted off, leaving a thin film of the specimen.

In cryo-TEM, the grid is immediately plunge-frozen in liquid ethane, at temperatures around -180 °C. The specimen is then kept in liquid nitrogen until it is inserted into the microscope and imaged at cryogenic temperatures. In cryo-TEM, the specimen is preserved in a hydrated environment, which is close to its native state. Whilst in nsTEM a solution of the heavy metal salt is then deposited on the support and the excess is blotted-off. The grid is then inserted and observed in the microscope at room temperature. In this method, the stain acts both as an embedding agent and a contrast-enhancing agent.

The following table shows the analysis potential of both techniques:

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15.  Could I get access to an example report from you?

Yes, just fill out the form on our Report Example page and you will get access to all example reports. Our example reports will give you deeper insight into our analyses and how our analyses can help you.

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What to do if you have a question or want to start a project with Vironova.

Feel free to contact and connect with us Vironovians at www.vironova.com/contact  or connect and follow us on LinkedIn.

We will get back to you in one business day to set up a meeting with our experts who will explain our processes and answer any of your questions.



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