EUNCL : EUropean Nanomedicine Characterization Laboratory
EUNCL is the European reference Nanomedicine Characterization Laboratory performing full physical, chemical and biological characterization of nanomedicinal products before regulatory application. The full characterization assay cascade has been permanently updated with regulators in response to needs. Thirty-plus nanomedicinal products were accepted by EUNCL between 2016 and 2019.
Starting date : may 2015 - nov 2019
Lifetime:48 months
Program in support
:
Status project : complete
CEA-Leti's contact :
Project Coordinator : CEA-Leti
Partners: - EMPA (CH)
- European Research Services NanoBioAnalytik Münster
- Trinity College (IR)
- Ispra (IT)
- SINTEF Trondheim (NO)
- University of Liverpool (UK)
- SAIC - Frederick (US)
Investment: € 5.6 m.
EC Contribution: € 5.6 m.
Number of patents: n/a
| Stakes
EUNCL is the European reference Nanomedicine Characterization Laboratory performing full physical, chemical and biological characterization of nanomedicinal products before regulatory application. The full characterization assay cascade has been permanently updated with regulators in response to needs. Thirty-plus nanomedicinal products were accepted by EUNCL between 2016 and 2019.
- General coordination of infrastructure
- Coordination of trans-national access
- Responsibility for physical and chemical characterization.
- Efficient synchronization and alignment with CEA-Liten Nano Safety Platform (PNS)
- Physical and chemical characterization of 5 nanomedicinal products
- EU leadership in characterization of nanomedicinal products
- Coordination of REFINE spin-off project on regulatory science framework of nanomedicinal products and nanobiomaterial-enabled medical devices.
- Strong attractiveness of Grenoble as a place for developing nanomedicinal products (formulation, characterization, scale-up manufacturing).
OBJECTIVES
- To provide a trans-disciplinary testing infrastructure covering a comprehensive set of preclinical characterisation assays(physical, chemical, in-vitro and in-vivo biological testing) allowing researchers to fully comprehend the biodistribution, metabolism, pharmacokinetics, safety profiles and immunological effects of nanoparticles used for medical applications (Med-NPs).
- To foster the use and deployment of standard operating procedures (SOPs), benchmark materials and quality management for the preclinical characterization of Med-NPs.
- To promote inter-sectorial and inter-disciplinary communication among key drivers of innovation, especially between developers and regulatory agencies.
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