Summary
The EU-NCL aims at fostering innovation in Nanomedicine by providing access to state of the art full characterisation of nanomaterials intended for medical applications, developed by public labs, spin–offs and innovative SMEs. The EU-NCL shall also serve as a European knowledge base for researchers and industry ensuring that European knowledge is documented in Europe for the benefit of the European economy, healthcare systems and patients.
Achievements
EUNCL is providing the full preclinical characterisation assays required prior to the regulatory submission. It's a network of 6 European laboratories with state-of-the-art infrastructure. EUNCL offers a service free of charge to the nanomedicine community. Its core expert team with complementary expertise provides knowledge to product developers. Nearly 30 assays addressing physicochemical and biological questions have been standardised and are constantly updated according to scientific progress. EUNCL raises regulatory awareness on upcoming challenges with the quality and safety evaluation of nanomedicines.
The establishment of the EUNCL benefits from the >10 years experience of the NCI-NCL, which contributes to the harmonisation of information requirements and test methods. EUNCL serves start-ups, SMEs and large companies developing nanomedicines.
Impact in international / European cooperation
• Charactersation tests;
• Characterisation of nanomaterial;
• Standardisation of analytical methods of nanomedical nanomaterials;
• Adapt the current regulation and approval process to Nanomedicine products;
• Easy access to nanocharacterisation for spin-offs.
