Assessment of the percentage of full recombinant adeno-associated virus particles in a gene therapy drug using CryoTEM (2022)
PLoS ONE 17(6): e0269139. Joint study with Takeda. First author Mathieu Colomb-Delsuc, Vironova AB.
Finding critical quality parameters using TEM-based image analysis
Josefina Nilsson; Presented at the 5th Bioprocessing Summit Europe, 2022
TEM analysis of purity, integrity and formulation changes in the production of viral vectors and vaccines
Qiong Wu; Presented at the 13th Annual Bioprocessing Summit, 2021
Harnessing the power of TEM and AI for rapid and routine analytical insights for gene therapy development
Saba Hussein Gore; Presented at the 4th Bioprocessing Summit Europe, 2021
Liposome characterization for drug delivery applications
Objective characterization of liposomal drug delivery platforms: Using cryoTEM and designated image analysis software
MiniTEM™ - Designed for nanoparticle characterization
MiniTEM™ TEM-based analysis system
Characterization of AAV samples using TEM
MiniTEM and TEM Services overview with AAV focus
ViroTEM TEM-based analysis system
VAS - Vironova Analyzer Software
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.
A comparative study of MiniTEM vs. DLS and NTA
Comparing MiniTEM with DLS Zetasizer Nano and NTA nanoSight NS300 performance when analyzing < 50 nm particles
Key considerations in gene therapy manufacturing for commercialization
Discussion about gene therapy manufacturing, including the latest in manufacturing methods, analytical analysis, and key regulatory considerations
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:
For other particles, please contact us. Our experts will suggest a TEM analysis method suitable for your product.
Vironova holds a Certificate of GMP Compliance of a Manufacturer issued by the Swedish Medical Products Agency.
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”.
Example reports are available for the following analyses: