Automated integrity analysis of AAV and Adenovirus This study highlights the possibility of automated viral integrity measurements of AAV and Adenovirus particles. The analysis is performed using MiniTEM-enabled automated imaging, particle detection, classification and quantification. It provides a metric for determining the proportion of intact or broken particles in virus samples.
Automated purity analysis of Adenovirus samples A metric for sample purity based on the ratio of the total area of debris to that of intact Adenovirus particles is presented in this study.
Detection of hemagglutinin spikes on influenza VLPs using automated MiniTEM analysis In this case study, six different purified influenza VLP samples taken after the downstream process were analyzed. Relative quantification of influenza VLP particles with hemagglutinin spikes, as well as the amount of particles without spikes, debris and baculovirus in each sample, was calculated and presented graphically. This information can be used to confirm that critical morphological features are maintained, and impurities removed, during the manufacturing process.
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.
A wide range of nanoparticles can be tested and analyzed using TEM. At Vironova we specialize in the following:
Quoting the Swedish Medical Products Agency, the certificate is for “Testing with the purpose of characterization, evaluation, quality assessment and quality control of particles in micro and nanometre scale (drug substances, intermediate drug substances, drug products) using negative stain Transmission Electron Microscopy and cryogenic Transmission Electron Microscopy with semi-automatic particle detection and analysis using software”.
