Quality-critical attributes particular to liposome drug products include physicochemical properties such as particle size distribution and morphology, e.g. their overall shape. Such properties will influence the biological activity and bio-distribution of liposomal-based drug and gene delivery platforms. Analytical techniques that provide objective and reliable information on liposome particle characteristics can thus help to improve product development processes and shorten the time to securing their final quality.
Cryo-transmission electron microscopy (cryoTEM) combined with image analysis using proprietary Vironova Analyzing Software (VAS) represents an optimized methodology for achieving this goal. By enabling semi-automated particle detection and classification analysis, statistically significant results are delivered in a time and cost-effective manner.
The study described here presents a typical liposomal characterization achieved by extracting relevant data of images obtained from cryoTEM using Vironova Analyzing Software. It includes analyses of size distribution and morphology, circularity, level of packaging/state of encapsulated drug, lamellarity and lipid bilayer thickness.