Modern medical and pharmaceutical research is developing a wide range of increasingly complex therapeutic agents and drugs and drug delivery vehicles. Alike viral vectors, LNPs, and exosomes, many of them have nanoparticular properties. Due to their size, complex structure, or even polydispersity, these entities cannot be sufficiently characterized and released for safe administration into humans by standard chromatography methods alone. Therefore, proper process and product characterization and validation is required, to allow for clinical and commercial drug product applications of these technologies.
Analytical ultracentrifugation (AUC) is an indispensable tool for the extended characterization of these classes of compounds. Nanolytics’ superior equipment, including the ahead-state-of-the-art detectors by Nanolytics Instruments, enhances the method’s capabilities. Our experienced team will optimize experimental design and evaluation in addressing these complex and challenging systems.
CASE STUDY: Heterogeneity of plasmid DNA
This system was analysed via sedimentation velocity with absorbance detection.
A predominant plasmid DNA monomer peak along with two minor conformation variants either with a lower or higher sedimentation coefficient is detected.
Unlike proteins, conformation-variants of nucleic acids can comprise substantial differences in frictional ratio and partial specific volume, resulting in comparatively large differences in sedimentation coefficients as in the present case. The remaining material represents aggregates.