The first ‘European Nanomedicine Characterization Laboratory’ (EU-NCL) has begun its work.
The goal is to help bring more nanomedicine candidates into the clinic and onto the market for the benefit of patients and the European pharmaceutical industry. To achieve this aim, the EU-NCL is partnered with the sole international reference facility, the ‘Nanotechnology Characterization Laboratory’ (US-NCL) of the US-National Cancer Institute, to get faster international harmonisation of analytical protocols. EU-NCL is also closely connected to national medicine agencies and the European Medicines Agency to continuously adapt its analytical services to the requests of regulators.
Commenting, Scott E McNeil, director of US-NCL, said: “We are excited to be part of this co-operative project between Europe and the US. We hope this collaboration will help standardise regulatory requirements for clinical evaluation and marketing of nanomedicines internationally. This venture holds great promise for using nanotechnologies to overcome cancer and other major diseases around the world.”
Empa, the Swiss Federal Laboratories for Materials Science and Technology, is part of the EU-NCL, a European project funded by Horizon 2020. Its goal is to reach a level of international excellence in nanomedicine characterisation for diseases like cancer, diabetes, inflammatory diseases or infections. This competence will be made accessible to all organisations developing candidate nanomedicines prior to their submission to regulatory agencies to get approval for clinical trials and, later on, for marketing authorisation.
EU-NCL, which is funded by the EU for a four-year period with nearly €5m, brings together nine partners from eight countries, including CEA-Tech in Leti and Liten, France, the co-ordinator of the project, and the Joint Research Centre of the European Commission in Ispra, Italy.
Within EU-NCL, six analytical facilities will offer transnational access to their existing analytical services for public and private developers, and will also develop new or improved analytical assays to keep EU-NCL at the cutting edge of nanomedicine characterisation. Another objective is to promote intersectoral and interdisciplinary communication among key drivers of innovation, especially between developers and regulatory agencies.