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cGMP Transmission Electron Microscopy (TEM) Services

Viral Safety & Cell Substrate Characterization for Biologics Developers

Minaris offers cGMP-compliant Transmission Electron Microscopy (TEM) services in the United States to support viral safety and advanced characterization programs for monoclonal antibodies (mAbs), vaccines, and cell & gene therapy products. With decades of experience supporting IND, BLA, and global regulatory submissions, our cGMP TEM services provide a critical, FDA-recognized method for detecting adventitious and endogenous viruses and supporting advanced characterization.

TEM delivers a unique visual confirmation of viral presence.  It’s a high-resolution imaging technique used to directly visualize very small particles, especially viruses—that are far below the resolution of light microscopy. Specialized equipment, deep expertise and highly trained scientists are required to perform this assay effectively and accurately, all of which are available at Minaris Advanced Testing in Philadelphia, U.S.

When is TEM Used?

Due to its unbiased nature and ability to detect unknown agents,
TEM is most often used as an orthogonal or investigational method in conjunction with
molecular and cell-based assays for:

Detection of virus and virus-like particles (VLPs)

Evaluation of retrovirus-like particles (RVLPs)

Support of cell bank characterization

Unprocessed bulk viral safety assessment

Starting point for viral clearance studies

Investigation of viral contamination events

Morphological confirmation during viral safety assessments

While molecular technologies such as NGS provide powerful sequence-based detection,
TEM offers direct visualization of viral particles or cells, providing complementary
evidence within a comprehensive testing program.

Part of an Integrated Testing Strategy

TEM is one component of a broader viral safety framework including cell bank characterization and unprocessed bulk testing. Minaris also provides:

  • • In vitro adventitious virus assays 
  • • Replication Competent Retrovirus (RCR) testing 
    • • 9CFR viral detection assays
  • • Titering and Viral quantification assays
  • • Molecular methods (including NGS ) 
  • • Sterility and mycoplasma testing 
  • • Viral clearance studies
  • • Genetic stability and identity testing
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Amulv Foci and Synscytia Light Microscopy

We work closely with our clients to design a risk-based, regulatorily aligned testing strategy tailored to product type and development stage. The team at Minaris understands how TEM data is positioned within regulatory submissions and can provide documentation aligned with current expectations under ICH Q5A and related guidances.

Why Partner with Minaris

  • • U.S.-based laboratory services
  • • Experienced virology and microscopy specialists
  • • cGMP-aligned processes
  • • Rapid project initiation
  • • Integration with broader safety testing services
  • • Support from early development through commercialization

We provide clear reporting, scientific interpretation, and regulatory-ready documentation to support your submission strategy.

Let’s Discuss Your Program

Whether you are establishing a new master cell bank, advancing a mAb, or developing a novel gene therapy platform, Minaris can support your viral safety and characterization needs with TEM services tailored to your product.

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Accurate, timely, and compliant testing is critical to advancing complex therapies. Minaris Advanced Testing delivers a comprehensive suite of GMP biosafety and characterization services designed to support every stage of your program, from early research through IND, clinical and commercial requirements. Our team provides the experience, responsiveness and support you need. Get in touch today.

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