The degradation of a particle’s structural integrity can indicate non-optimal processing conditions or formulations, and more significantly, can lead to poor transgene delivery.
The monitoring of morphological changes, such as a partial or complete particle breakage, or the loss of critical surface features during process development is hence of prime importance.
At QuTEM, we offer the ability to use TEM as a comprehensive analytical option for assessing morphological changes during bioprocessing. With the aid of our advanced image analysis software, we provide objective and quantitative statistics by evaluating the ratio of observed subpopulations such as intact or broken particles for a variety of particle types.
At QuTEM, the integrity assessment is typically performed for the following particle types:
Our analysis workflow includes: