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dc.contributor.authorCaputo, Fanny
dc.contributor.authorMehn, Dora
dc.contributor.authorClogston, Jeffrey
dc.contributor.authorRösslein, Matthias
dc.contributor.authorPrina-Mello, Adriele
dc.contributor.authorBorgos, Sven Even F.
dc.contributor.authorGioria, Sabrina
dc.contributor.authorCalzolai, Luigi
dc.description.abstractAsymmetric-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 European Union Nanomedicine Characterization Laboratory (EUNCL) and the National Cancer Institute-Nanotechnology Characterisation Laboratory (NCI-NCL). 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 analytical technique to obtain critical information on a material 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 the ability to implement a powerful and highly complex analytical technique such as MD-AF4 to the demanding quality standards set by the regulatory authorities for the pre-clinical safety characterization of nanomedicines.en_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.subjectregulatory frameworken_US
dc.subjectstandard operating proceduresen_US
dc.subjectnanoparticle stabilityen_US
dc.subjectparticle size distributionen_US
dc.subjectfield flow fractionationen_US
dc.titleAsymmetric-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 Laboratoryen_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.rights.holder© 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license ( )en_US
dc.source.journalJournal of Chromatography Aen_US

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