Executive Summary
Negative stain transmission electron microscopy (TEM) is a powerful method for viral particle detection, characterization, and contamination assessment in biologics and advanced therapy products. Unlike molecular assays, TEM provides direct visualization of virus-like particles without requiring virus-specific reagents, enabling unbiased detection of known and unknown contaminants.
With the ability to image particles ranging from ~20 nm to several hundred nanometers, negative stain TEM plays a critical role in viral safety testing, adventitious agent detection, and regulatory compliance for biologics manufacturing.
This white paper outlines the scientific principles of negative stain TEM, Minaris Advanced Testing’s standardized quantification methodology, and the GMP-compliant infrastructure supporting reliable, reproducible results.
Download the full white paper to learn more.
Key Takeaways
- Unbiased viral detection through direct particle visualization
- Detects unknown or adventitious viral contaminants
- High-resolution imaging of particles ~20 nm to several hundred nanometers
- Standardized, regulatory-aligned methodology
- Enhanced quantitative accuracy using a latex bead reference system
- Critical support for biologics, cell therapy, and gene therapy programs
About This White Paper
Read this white paper to explore the role of negative stain transmission electron microscopy as a critical analytical tool in biologics development and manufacturing. It details:
- The scientific principles behind negative stain TEM
- Sample preparation and visualization methodology
- Quantitative strategies to enhance reproducibility
- Applications in viral particle characterization and contamination assessment
- The GMP-compliant infrastructure supporting Minaris Advanced Testing services
Whether used for routine viral safety testing, contamination investigations, or process development support, negative stain TEM remains a foundational technology for direct viral particle assessment
Who should read this white paper?
- CMC and Process Development Scientists
- Quality Control and Quality Assurance Professionals
- Viral Safety and Biosafety Experts
- Regulatory Affairs Teams
- Biologics Manufacturing and Technical Operations Leaders
- Cell and Gene Therapy Developers
