Viral Safety
Detect, characterize, and quantify viral contaminants in cell substrates and biological products in accordance with ICH Q5A(R2).
Transmission Electron Microscopy (TEM) provides direct visualization of viral particles and remains one of the most powerful orthogonal methods for the viral safety assessment of biological products.
Unlike targeted molecular assays, TEM enables non-targeted detection of known and unknown viral contaminants, virus-like particles (VLPs), and retrovirus-like particles (RVLPs) based on their morphology. This makes TEM particularly valuable for contamination investigations, cell bank characterization, and routine viral safety testing.
Under ICH Q5A(R2), TEM is specifically recommended for:
- Cell bank characterization
- Bulk Harvest testing
- Detection and classification of retrovirus-like particles
- Adventitious agent testing
- Quantification of viral particles in cell-free material
Neotem provides GMP-compliant viral safety testing supported by more than 25 years of TEM expertise. Our experienced scientists deliver rapid, regulatory-ready assessments to support biologics, vaccines, and advanced therapy products.
Applications
- Adventitious virus detection
- Cell bank characterization
- Bulk harvest testing
- Retrovirus-like particle classification
- Contamination investigations
- Orthogonal viral safety support
Fast Turnaround
Results for bulk harvest testing can be issued within 5 working days, helping clients rapidly assess safety concerns, minimize manufacturing delays, and support product release decisions.
