QuTEM (formerly Vironova BioAnalytics) specializes in characterization analysis of nanoparticles using transmission electron microscopy (TEM) and image analysis, with a specific focus on advanced therapeutics. We operate a fully GMP-certified laboratory in Stockholm, Sweden.

We utilize negative stain TEM (nsTEM) and cryogenic TEM (cryoTEM) for both BSL-1 and BSL-2 samples, using CFR21 part 11 compliant image analysis software. Our expertise lies in sample preparation, imaging, and image analysis.

Our extensive analysis portfolio covers a wide range of particles, including adeno-associated virus (AAV), adenoviral vector (AV), bacteriophage, extracellular vesicles (EV), lentiviral vector (LV), liposomes, lipid nanoparticles (LNP), modified vaccinia Ankara virus (MVA), virus-like particles (VLP), and vesicular stomatitis virus (VSV), among others.

QuTEM also performs validation studies of analytical protocols to assure the quality and consistency of TEM testing for our clients and their products. These studies are designed and executed according to ICH Q2 R1 guidelines.