 
   
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.
 
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               Starting date :  may 2015 - nov 2019  
               
               Lifetime:48 months 
               
               
                 
               Program in support  
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               Status project : complete
               
 
                
                   
                     CEA-Leti's contact :
                                                
 
                 
 
               Project Coordinator : CEA-Leti 
               
               Partners:  EMPA (CH)
European Research Services NanoBioAnalytik MünsterTrinity 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 accessResponsibility 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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