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 of nanopharmaceuticals. However, the application of robust and high quality standard operating procedures (SOPs) is critical for accurate measurements, especially as these complex drug nanoformulations are most often inherently polydisperse. In this review we describe a unique international collaboration that lead to the development of a robust SOP for the measurement of physical-chemical properties of nanopharmaceuticals by multi-detector AF4 (MD-AF4) involving two state of the art infrastructures in the field of nanomedicine, the NCI-Nanotechnology Characterisation Laboratory (NCI-NCL) and the European Nanomedicine Characterisation Laboratory (EUNCL). We present examples of how MD-AF4 has been used for the analysis of key quality attributes, such as particle size, shape, drug loading and stability of complex nanomedicine formulations. The results highlight that MD-AF4 is a very versatile technique to obtain critical information on a material’s particle size distribution, polydispersity and qualitative information on drug loading. The ability to conduct analysis in complex physiological matrices is an additional very important advantage of MD-AF4 over many other analytical techniques used in the field for stability studies. Overall, the joint NCI-NCL/EUNCL experience demonstrates that it is possible to implement a powerful and highly complex technique such as MD-AF4 to the demanding quality standards set by global regulatory authorities for the pre-clinical safety characterization of nanomedicines.
CAPUTO Fanny;
MĖHN Dóra;
CLOGSTON Jeffrey;
ROSSLEIN Matthias;
PRINA-MELLO Adriele;
BORGOS Sven Even;
GIORIA Sabrina;
CALZOLAI Luigi;
2021-09-15
ELSEVIER SCIENCE BV
JRC121626
0021-9673 (online),
https://www.sciencedirect.com/science/article/pii/S0021967320310414?via%3Dihub,
https://publications.jrc.ec.europa.eu/repository/handle/JRC121626,
10.1016/j.chroma.2020.461767 (online),
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