Caputo, F; Favre, G; Borchard, G; Calzolai, L; Fisicaro, P; Frejafon, E; Gunday-Tureli, N; Koltsor, D; Minelli, C; Nelson, B C; Parot, J; Prima-Mello, A; Zou, S; Ouf, F X (2024) Toward an international standardisation roadmap for nanomedicine. Drug Delivery and Translational Research, 14. pp. 2578-2588.

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Abstract

The French National Measurement Institute (LNE) initiated a series of events to identify priorities for test methods and their harmonisation that directly address regulatory needs in Nanomedicine. One of these workshops-+- entitled "The International Standardisation Roadmap for Nanomedicine" held in October 2023 (Paris, France) brought together key experts in the characterisation of nanomedicines and medical products containing nanomaterials, including the Joint Research Centre of the European Commission, SINTEF Industry and the metrology institutes of France, the UK, the USA and Canada. The participants also included representatives from two flagship initiatives of the European Commission that support innovation in nanotechnology-based health products (PHOENIX and SAFE-n-MEDTECH Open Innovation Test Beds), representatives of a working party on mRNA vaccines at the European Directorate for the Quality of Medicines (EDQM) and members of international standardisation and pre-normative organisations (including CEN, ISO, ASTM, VAMAS). The event provided a unique opportunity for the 74 participants, predominantly from industry, to deliberate on how EU funded Open Innovation Test Beds (OITBs), metrology institutes and the standardisation community could support and accelerate the commercialisation of nanomedicine-based products. It also served as a platform to gain insights into ongoing initiatives and to advocate for a more active role of the European Metrology community in fostering connections among the diverse stakeholders involved.

Item Type:	Article
Subjects:	Biotechnology > Biopharmaceutical Manufacturing and Characterisation
Divisions:	Chemical & Biological Sciences
Identification number/DOI:	10.1007/s13346-024-01646-2
Last Modified:	21 Oct 2024 09:56
URI:	https://eprintspublications.npl.co.uk/id/eprint/10079