Presented by: Fanny Caputo, Ph.D., SINTEF, and Christoph Johann, Ph.D., Wyatt Technology
Presented Live: December 15, 2020
Multi-detector asymmetric-flow field-flow fractionation (MD-AF4) has been recognized as an invaluable tool for the characterization of particle size, polydispersity, drug loading and stability of nanopharmaceuticals. The application of robust and high-quality standard operating procedures (SOPs) is critical for accurate and reliable measurements, especially as these complex drug nano-formulations are most often inherently polydisperse.
A unique international collaboration, involving two state-of-the-art infrastructures in the field of nanomedicine—the European Nanomedicine Characterization Laboratory (EUNCL) and the National Cancer Institute Nanotechnology Characterization Laboratory (NCI-NCL)—has led to the development of a robust SOP for the measurement of physical-chemical properties of nanopharmaceuticals by MD-AF4. After a brief overview of MD-AF4 principles and instrumentation, this webinar presents examples of how MD-AF4 quantifies key quality attributes of complex nanomedicine formulations such as particle size distributions, shape, concentration and stability, using the SOP guidelines. Particular focus is given to the characterization of liposomal products and of lipid-based nanoparticles (LNPs) for RNA delivery. Finally, current efforts within ASTM for standardization of methods based on MD-AF4 are presented.