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Development of new metrological network for standardisation of nanotherapeutics in Europe

Europe is facing significant healthcare challenges driven by an ageing population coupled with an increase in chronic diseases like cancer, diabetes, heart disease, and brain conditions. These conditions require diverse and complex treatments, which increase healthcare costs. Nanomedicine and nano-enabled medical devices therapeutics (defined here as nanotherapeutics) are vital for tackling health and societal challenges, providing versatile technical solutions.

Metrology Partnership project Metrology for innovative nanotherapeutics (22HLT04, MetrINo) is responding to the immediate metrological needs expressed by industry, regulatory agencies, and policymakers to develop and validate traceable measurement methods and reference materials candidates for the assessment of the critical quality attributes of nanotherapeutics. The project focuses on clinical formulations, including synthetic lipid nanoparticles and liposomes used for gene therapy or as vaccines (e.g. COVID-19), and metal oxide nanoparticles used for localised cancer treatment or as contrast agents. By providing fit for purpose methodologies, standardised methods and reference material candidates to regulators and industrial stakeholders, the project is supporting their clinical translation, providing more efficacious nanotherapeutics with fewer side effects to improve the patient’s quality of life and enhancing the competitiveness of the European health technology industry.

METRINO Academy

A short webinar series is available. This is designed to translate METRINO outcomes into practical, user-oriented guidance for the broader community, with a focus on real life decisions such as quality control, reproducibility and standardisation readiness.

• Session 1 - The industrialisation of nanomedicines with Nanobiotix
• Session 2 - Choosing the right measurement method
• Session 3 - RNA-LNP analytics and interlab comparison
• Session 4 - Standardising correlative imaging for nanomedicine
• Session 5 – Unlocking surface chemistry in nanomedicine

Project coordinator Robin Schürmann from PTB said

‘One of MetrINo’s key achievements is translating advanced metrology into practical tools and guidance that can be used directly by researchers, industry and regulators. Through the MetrINo Academy, we are fostering a shared understanding of quality, reproducibility, and standardisation in nanotherapeutics. This ultimately supports the safe and rapid clinical translation of these therapies for the benefit of patients.’

This Metrology Partnership project has received funding from the European Partnership on Metrology, co-financed by the European Union Horizon Europe Research and Innovation Programme and from the Participating States.

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