Drug Manufacturing Process Validation

NIS Molecule

TEM provides critical insight for efficient, consistent nanoparticle formulation in drug manufacturing.

Ensuring the stability and function of nanoparticle formulations from scale-up through process development, manufacturing, validation 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.

Cryo-TEM allows for direct visualization and comprehensive characterization of  viral vector morphology.

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

NIS offers enhanced drug manufacturing and process control for improved final product performance.

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

Frequently Asked Questions

Microscopic imagery of Drug Manufacturing Process Validation
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