Drug Manufacturing Process Validation

NIS Molecule
NIS Protein Structure
NIS Protein Structure

Ensuring the stability and function of nanoparticle formulations from scale-up through process development, manufacturing and final use by a patient requires continuous monitoring of critical quality attributes (CQAs). During drug, gene therapy and vaccine vector manufacturing, expertly deployed transmission electron microscopy (TEM) can provide critical structural information. This data can help scientists navigate the best route to efficient, consistent manufacturing that ensures a safer and best performing final product.

TEM, and in particular, cryo-EM allows for the direct visualization of viral vectors and a comprehensive characterization of morphology. The direct analysis capability allows for the monitoring of:

NIS helps control critical quality attributes during scale-up

Imagine what you can achieve by gaining a more thorough way of monitoring and controlling critical quality attributes during manufacturing and process control. NanoImaging Services makes this possible. Our services help navigate you to the best product fast, saving you time, money, and ultimately a better performing final product.

Samples We've Imaged

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Nanoparticles We've Imaged

Extracellular Vesicles
Iron nanoparticles
Lipid Nanoparticles (LNPs), with mRNA, RNA, DNA payloads
Polymeric nanoparticles
Protein (subunit) based nanoparticles
Virus-Like Particles (VLPs)
Viruses, attenuated and recombinant (BSL-2 & below)
NIS Mountain Hero