
QuTEM's nanoparticle characterization services use transmission electron microscopy (TEM) to bring a new level of quality control to therapeutic nanoparticles — from R&D through GMP-certified release. Every analysis in our portfolio runs on Gridsee, our proprietary software tuned for TEM data management, image analysis and reporting.
Our portfolio covers a wide range of therapeutic nanoparticles — including AAVs, adenoviral and lentiviral vectors, lipid nanoparticles (LNPs), liposomes, extracellular vesicles (EVs), bacteriophages and virus-like particles. For each, we provide quantitative analyses such as aggregation, integrity, size distribution, genome length and vector content, delivered as reliable, traceable data. Every method can be validated to ICH Q2 (R1) guidelines, supporting your product from early research through GMP release.

QuTEM performs validation studies of analytical protocols to assure the quality and consistency of TEM testing for our clients and their products. The studies are designed and executed according to ICH Q2 R2 guidelines.
Contact our scientists for a customized characterization