The European Nanomedicine Characterization Laboratory (EU-NCL) launched last week with the goal of speeding up nanomedicine candidates’ path to clinical trials and approvals, for the “benefit of patients and the European pharmaceutical industry.”
An analytical facility set up within the Particles-Biology Interactions unit of Swiss Federal Laboratories for Materials Science and Technology in Switzerland is the first of six planned sites which will offer access to existing characterisation services to public and private drug developers.
The project will be funded over the next four years by the EU programme Horizon 2020, and by institutions in nine countries:
- CEA-Tech in Leti and Liten, France;
- Joint Research Centre of the European Commission in Ispra, Italy;
- European Research Services GmbH in Münster, Germany;
- Leidos Biomedical Research, Inc. in Frederick, USA;
- Trinity College in Dublin, Ireland;
- SINTEF in Oslo, Norway;
- University of Liverpool in the UK;
- Empa, the Swiss Federal Laboratories for Materials Science and Technology in St. Gallen, Switzerland;
- Westfälische Wilhelms-Universität (WWU) and Gesellschaft für Bioanalytik, in Münster, Germany.
The partnering institutions will provide a “trans-disciplinary testing infrastructure,” said the co-ordinators, covering preclinical characterization assays (physical, chemical, in vitro and in vivo biological testing), to help nanomedicine researchers understand the drugs’ biodistribution, metabolism, pharmacokinetics, safety profiles and immunological effects.
The organisers said EU-NCL will also foster use of standard operating procedures (SOPs), benchmark materials and quality management for the preclinical characterization of medicinal nano-products.
“Yet another objective is to promote intersectoral and interdisciplinary communication among key drivers of innovation, especially between developers and regulatory agencies,” they said.
The information will be 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 authorization.”
EU-NCL says it is prepared to adapt to the needs of national medicines agencies to help bring drugs to market. It is partnered with the US National Cancer Institute’s Nanotechnology Characterization Laboratory (US-NCL) for “faster international harmonization of analytical protocols.”
The lab is also closely connected to national pharma regulators and the European Medicines Agency “to continuously adapt its analytical services to requests of regulators.”
“EU-NCL is designed, organized and operated according to the highest EU regulatory and quality standards,” said the lab.
Scott McNeil, Director of US-NCL, said the American institute was excited to be part of the cooperative transatlantic project:
“We hope this collaboration will help standardize 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.”