Transmission Electron Microscopy
Comprehensive quality assessment with TEM testing
TEM
Transmission Electron Microscopy testing (TEM testing) is a powerful imaging technique used to visualize the ultrastructure of cells and viruses at the nanometer scale, providing detailed insights into their morphology and composition.
TEM provides high-resolution imaging that can detect and identify potential contaminants, ensuring the integrity and safety of biological materials (e.g., cell lines, virus seeds, bulk harvests) used in production. TEM testing enables visualization of virus particles, determination of particle size and morphology, identification of virus particle location, and quantification.
Viruses and virus-like particles (VLPs) are observed by TEM on thin sections of pelleted samples embedded in resin using positive staining. Furthermore, suspended viruses and VLPs can be analyzed in buffer or media supernatant using negative staining.
For the detection of retrovirus and other viral contaminants in cell substrates used in the manufacture of biopharmaceuticals, guidelines from the Federal Drug Administration (FDA), the Center of Biologics Evaluation and Research (CBER), and the European Medicines Agency (EMA), as well as ICH guideline Q5A (R2) recommend the use of TEM.
With our GMP-certified TEM testing, you gain access to a suite of advanced imaging and analysis tools tailored specifically for the biopharmaceutical industry. This includes TEM testing for GMP-compliant batch release.
From analyzing cell substrates used in the production of biologics to characterizing viral vectors and ensuring CMC, our GMP-compliant TEM testing provides the comprehensive insight you need to drive innovation and ensure regulatory compliance.