Nanoparticle
Characterization

NIS Molecule

One Study, Multiple Answers

Cryo-TEM imaging is a vital technique for nanoparticle characterization, providing detailed quantitative and qualitative analysis of your formulation with just one study. 

Cryo-TEM & TEM imaging reveal Critical Quality Attributes (CQAs) and structural details that other methods miss, using only a small amount of sample.

From R&D through GMP, we provide

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Unparalleled Partnership

We provide high quality cryo-TEM & TEM images & a seamless workflow, across the pipeline from R&D through GMP.

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Unrivaled
Insights

Gain crucial answers, like size and payload distribution, with our proprietary in-house developed machine learning algorithms.

Our Services
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Unmatched
Expertise

With 240+ cumulative years of cryo-EM experience, we are the most experienced nanoparticle characterization CRO.

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Accelerate Drug Discovery with Cryo-TEM

Cryo-TEM can unveil many aspects of a sample in just one study, including particle size distribution, drug encapsulation, shape, morphology, impurities, and integrity, all with only ~50μl of sample

Cryo-TEM is a powerful orthogonal technique to complement your nanoparticle characterization toolkit.

Method Validation for Final Formulations

We offer method validation services to analyze critical quality attributes for regulatory submissions.

GMP compliant cryo-TEM studies can provide answers about: 

  • Batch-to-batch Reproducibility
  • Scale Up
  • Comparability
  • Stability
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Cryo-TEM & TEM for Nanoparticle Characterization

We provide quick, flexible, and cost-effective access to the answers cryo-TEM & negative stain TEM can reveal.

Crucial Insights into Your Formulation

From R&D through to GMP method validation and regulatory filings, negative stain TEM & cryo-TEM per-particle imaging complement your nanoparticle characterization toolkit in any stage of the pipeline.

Precise Nanoparticle Characterization

Access the power of cryo-TEM & negative stain TEM imaging along with our proprietary, automated analysis to get a more in-depth view earlier, fast-tracking your therapeutic development.

Characterize Your Nanoparticles

Therapeutic nanoparticles are complex, and can vary in composition, shape, and size. 

Nanoparticle size, shape, lamellarity and morphology affect drug incorporation, stability, and release, which in turn affect cell toxicity, targeting, and therapeutic efficacy. In addition, the study of drug cargo encapsulation when looking at gene or drug delivery systems is crucial, as the presence of many empty particles or impurities affects immunogenic response.

Cryo-TEM & negative stain TEM can evaluate multiple CQA's with one study.

Our Nanoparticle Experience

220

+

AAV samples imaged; 3D structure of AAV solved to 1.8 Å

3,700

+

Liposomal samples imaged, including LNP, EV, and OMV projects

2,900

+

Virus and VLP samples imaged

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Samples We Can Image with Cryo or NS TEM

  • Extracellular Vesicles & Exosomes
  • Extracellular Vesicles & Exosomes
  • Inorganic Nanoparticles
  • Inorganic Nanoparticles
  • Lipid Nanoformulations
  • Lipid Nanoformulations
  • Other Samples
  • Other Samples
  • Polymeric Nanoparticles
  • Polymeric Nanoparticles
  • Protein Based Nanoparticles
  • Protein Based Nanoparticles
  • Two Component Systems
  • Two Component Systems
  • Virus & Virus-Like Particles
  • Virus & Virus-Like Particles

Cryo-TEM in Action

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Purification of a recombinant oncolytic virus from clarified cell culture media by anion exchange monolith chromatography

July 3, 2023
rNDV can be effectively captured and purified from clarified cell culture without a load conditioning step and that the CIMmultus QA column is not sensitive to typical cell culture pH and conductivity variations within the investigated conditions (pH 7–8; conductivity: 5–17 mS/cm).
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Stressed stability and protective efficacy of lead lyophilized formulations of ID93+GLA-SE tuberculosis vaccine

June 19, 2023
Cryo-TEM per-particle imaging is a crucial tool for analyzing vaccine stability.
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Nonclinical pharmacokinetics and biodistribution of VSV-GP using methods to decouple input drug disposition and viral replication

March 9, 2023
Replication-competent oncolytic viruses (OVs) are emerging and promising cancer immunotherapies with demonstrable clinical efficacy.
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Immunogenicity and protection of a variant nanoparticle vaccine that confers broad neutralization against SARS-CoV-2 variants

February 28, 2023
Cryo-TEM imaging can be a powerful tool for determining the structure of antibody antigen complexes, such as those in SARS-CoV-2 Beta B.1.351.
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Optimizing a Multi-Component Intranasal Entamoeba Histolytica Vaccine Formulation Using a Design of Experiments Strategy

June 24, 2021
Cryo-TEM is used in Preclinical Vaccine Development for a Multi-Component Intranasal Entamoeba Histolytica Vaccine Formulation.
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SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice

January 14, 2021
Researchers show that a full-length, stabilized prefusion SARS-CoV-2 S glycoprotein vaccine (NVX-CoV2373) adjuvanted by Matrix-M can induce high levels of functional immunity in mice and baboons, and protects mice expressing hACE2 receptors in a live SARS-CoV-2 challenge. The functional immunity induced by this nanoparticle vaccine and Matrix-M adjuvant clearly depends on both the adjuvant and antigen components and mirrors the human experience with influenza hemagglutinin vaccine and a naïve population with Ebola recombinant protein nanoparticle vaccines.
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Frequently Asked Questions

Is cryo-TEM imaging with NIS GMP compliant?

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Can I see an example report of nanoparticle characterization and analysis?

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What can cryo-TEM tell me about my nanoparticles or nanomedicines?

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Why should I use cryo-TEM instead of Dynamic Light Scattering (DLS) to measure particle size?

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Why should I use cryo-TEM instead of analytical ultracentrifugation sedimentation velocity (AUC-SV) to measure full/empty capsids for samples like Adeno-associated viruses (AAVs)?

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Why should I use cryo-TEM in addition to other RNA encapsulation methods?

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How is cryogenic transmission electron microscopy (cryo-TEM) different than transmission electron microscopy (TEM)?

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What kind of samples do you have experience with?

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What is the size range of nanoparticles you can image with cryo-TEM?

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What is the likelihood for success in characterizing my nanoparticle sample?

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What quantity of my sample is required?

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Are all reagents and buffer conditions amenable to cryo-EM?

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What are the turnaround times to receive images and a report?

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Does NIS handle documentation or paperwork?

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