Vironova is a service provider specialized in transmission electron microscopy (TEM) analysis of vaccines, gene therapy and drug delivery particles such as viruses and liposomes. Vironova offers a complete GMP-certified TEM analysis package that includes both negative stain (nsTEM) analysis and cryogenic (cryoTEM) analysis, each providing powerful image datasets, quantitative data, and conclusions from the analysis.
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 actually happens when conditions are changed in upstream and downstream processes or product formulations.
Our service team uses the in-house developed 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. The automation that VAS provides allows Vironova EM services to deliver high-quality images and accurate quantitative data timely and cost-effectively.
Virus particle packaging analysis with cryoTEM in combination with VAS is a patented method and the first validated method in the world for AAV percentage-full-capsid analysis. This method is recommended for batch release testing and QC of AAV based gene therapy products.
Our experts will tailor the analysis to address your specific questions.
The report will contain: