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EU-NCL- First call for characterisation of injectable nanomedicines addressing cancer

The recently established European Nanomedicine Characterisation Laboratory (EU-NCL) aims at providing critical infrastructure and characterisation services that are needed to analyse physical and chemical attributes, in vitro biological properties, and in vivo characteristics of emerging nanomedicines ready for translation and clinical trials.
EU-NCL- First call for characterisation of injectable nanomedicines addressing cancer

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EU-NCL- First call for characterisation of injectable nanomedicines addressing cancer

The recently established European Nanomedicine Characterisation Laboratory (EU-NCL) aims at providing critical infrastructure and characterisation services that are needed to analyse physical and chemical attributes, in vitro biological properties, and in vivo characteristics of emerging nanomedicines ready for translation and clinical trials.

Context

The use of nanotechnology in healthcare promises new diagnostic opportunities and innovative therapeutic concepts that may help to tackle major medical challenges such as cancer, neurodegenerative diseases and antimicrobial resistance.

Challenge

However, the manufacturing process of nanomedicines is sophisticated, and quality inconsistencies between batches must be carefully monitored before clinical applications can be considered. Furthermore, safety concerns related to the use of nanomaterials must be addressed as early as possible during product development.

The recently established European Nanomedicine Characterisation laboratory (EU-NCL)[1] will address these issues by providing the critical infrastructure and characterisation services that are needed to analyse physical and chemical attributes, in vitro biological properties, and in vivo characteristics of emerging nanomedicines ready for translation and clinical trials.

Service

The EU-NCL services will be accessible to all organisations based in Europe and developing candidate nanomedicines, both prior to their submission to regulatory agencies for clinical trials approval and at a later stage for marketing authorisation. Product developers will benefit from a detailed and confidential characterisation data set that supports their decision making for further product development. EUNCL is NOT a CRO[2] performing GLP characterisation but a Research Infrastructure offering access to state of the art analytical assays for candidate nanomedicines. In the longer term, the scientific and regulatory communities will also profit from the EU-NCL database – containing results derived from highly standardised tests – that will allow a better understanding of how the physical and chemical properties of a material relate to their biological effects. Such a comprehensive database is essential to develop methods and tools that can help in early prediction of toxicological effects and bio-incompatibility.

Focus

The EU-NCL characterisation platform is intended to assess all categories of nanomedicines developed in the EU. The first characterisation campaign will be dedicated to medicinal nanoparticles based on organic compounds with proposed application in cancer treatment and/or diagnosis via the intravenous route.

The submission deadline for the first campaign is April 15th this year. More information on the application procedure can be found at http://www.euncl.eu/working-with-us/call-for-proposals/.

 



[1] Funded by the Framework Programme H2020 of the European Commission (grant n° 654190)

[2] Contract Research Organisation

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