Assessment of the size distribution for particles in a given sample is an essential characterization step in pharmaceutical and biotechnology process development, formulation, and production. Particle size distribution is directly linked to many other product attributes and can affect their performance.
Particle size distribution analysis is an established procedure in many laboratories.
However, standard nanoparticle sizing methods can feature lengthy procedures and/or be prone to bias introduced by contaminants. We have developed advanced image analysis software for semi-automated particle contouring and sizing that provides precise particle size distribution measurement for nanometer to sub-micron particles in heterogeneous and homogeneous sample solutions. These analyses help answer questions regarding batch or lot similarities and consistency, biosimilarity, and to reconcile results from size measurements obtained via other methods. This service can be used with negative stain and cryo-TEM techniques.
We’ve performed size distribution analysis on nearly 800 samples (predominantly liposomal/LNPs; vaccine, virus or virus-like particle samples; and 'other' samples such as iron sucrose, micelles and more.)