Scientists from the EU's Joint Research Center (JRC) in close collaboration with European and US researchers have reviewed and developed robust methods and procedures for measuring the accurate size of nanoparticles enabled medicinal products in complex biological environments (Journal of Controlled Release, "Measuring particle size distribution of nanoparticle enabled medicinal products, the joint view of EUNCL and NCI-NCL. A step by step approach combining orthogonal measurements with increasing complexity").
It is important to improve effectiveness and reduce costs to bring nanotechnology based medicinal products on the market.
The application of nanotechnology in healthcare has a great potential to address unmet medical needs by providing better diagnostics and therapy. A broad range of nanomedicines have been investigated so far for medical applications, but there are still problems in successfully translating laboratory research to clinically approved nanomedicines.
The size of nanomaterials in 'nanomedicine' is a key quality attribute, but their accurate measurement is still an issue.
The JRC, in close collaboration with researchers from the French CEA, Swiss EMPA, US NCI-NCL and Irish Trinity College, has developed a common strategy for measuring the particle size distribution of nanomedicines.
A quick preliminary step to assess sample integrity and stability by low resolution techniques is followed by the combination of complementary high resolution sizing measurements performed both in simple buffers and in complex biological media.
This work is part of the collaboration between the US Nanotechnology Characterization Laboratory (NCI-NCL) and the European Nanomedicine Characterisation Laboratory (EUNCL). It has led to high quality, accurate, determination of particle size distribution.
Standard operating procedures for the assessment of nanomedicines, including the measurements of particle size distribution, are publicly available and EUNCL and NCI-NCL are offering wide access to their ‘state of the art’ characterisation platforms.
European Commission. Posted: May 15, 2019.