Asymmetric-flow field-flow fractionation for measuring particle size, drug loading and (in)stability of nanopharmaceuticals. The joint view of European Union Nanomedicine Characterization Laboratory and National Cancer Institute - Nanotechnology Characterization Laboratory

Asymmetric-flow field-flow fractionation (AF4) has been recognized as an invaluable tool for the characterisation of particle size, polydispersity, drug loading and stability nanopharmaceuticals. However, application robust high quality standard operating procedures (SOPs) is critical accurate measurements, especially these complex nanoformulations are most often inherently polydisperse. In this review we describe a unique international collaboration that lead to development SOP measurement physical-chemical properties nanopharmaceuticals by multi-detector AF4 (MD-AF4) involving two state art infrastructures in field nanomedicine, European Union Nanomedicine Characterization Laboratory (EUNCL) National Cancer Institute-Nanotechnology Characterisation (NCI-NCL). We present examples how MD-AF4 used analysis key attributes, such shape, nanomedicine formulations. The results highlight very versatile analytical technique obtain information on material size distribution, polydispersity qualitative loading. ability conduct physiological matrices additional important advantage over many other techniques studies. Overall, joint NCI-NCL/EUNCL experience demonstrates implement powerful highly demanding standards set regulatory authorities pre-clinical safety characterization nanomedicines.