Your first choice of provider of transmission electron microscopy (TEM) analysis of vaccines, gene therapy and drug delivery particles such as viruses and liposomes.
Vironova’s EM services 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.
EM services 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.
CryoTEM images of Adeno associated virus (AAV)
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.
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.
Currently available for AAV projects, our fast lane offers a guaranteed turnover time of only 4 business days.
Our fast lane provides the same expertise but it speeds up your bioprocessing project timeline. Your project can be executed in our GMP-certified laboratory if needed.
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.
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.
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.
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”.
An image from our GMP certified laboratory
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.
EM services offer 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.
Please contact us through our website filling up the send us a request form or by email to info@vironova.com. One of our personnel will contact you to set up a meeting with our scientists who will explain our processes and answer your questions.
When you decide to do a service with us, we will initiate the project by preparing the required documents according to our procedures. After all the documentation is completed, we will inform you that we can receive your samples. Our delivery team will guide you through properly shipping your samples. The analysis will be performed by our senior scientists in Stockholm and the analytical report will be finalized and sent to you within 10-15 working days after the project started.
All the image analyses provided by our services are performed using our proprietary software Vironova analyzer software (VAS). VAS was specifically designed and built to answer the needs of using TEM as an analytical tool for nanoparticle characterization. Moreover, the software is FDA 21 CFR Part 11 compliant being in accordance with our EM Services GMP certified services for TEM analytics.
Your project will be performed during the reserved time slot, images and the report will be exported within 10-15 working days after the project started.
We require a minimum volume of 50 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.
Since we are a GMP facility we have internal standard operating procedures that ensures a good sample traceability. After analysis and the thawing process, the remaining samples & buffers are stored at 2-8oC or at room temperature for a maximum of 30 days. 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. Please contact us if you have a special request.
The sample submission form (SSF) is the document with the unique project number which can be traced back to the unique sample name. For this reason, it is of extreme importance that our delivery team receives the SSF together with the sample shipment. This ensures the traceability between the sample shipment and the project.
Let our microscopist help you out!
If you have any further questions we encourage you to contact us so our microscopists can help you.
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