Metrology for Innovative NanoTherapeutics

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Forschungsstelle

SBFI

Projektnummer

23.00360

Projekttitel

Metrology for Innovative NanoTherapeutics

Texte zu diesem Projekt

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Abstract	-	-	-

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Abstract (Englisch)	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. This project responds to the immediate metrological needs expressed by industry, regulatory agencies and policymakers to develop and validate traceable measurement methods and candidate reference materials (CRMs) for the assessment of the critical quality attributes (CQAs) of nanotherapeutics. The project will focus on clinical formulations, including synthetic lipid-based nanotherapeutics, including lipid nanoparticles (LNPs) for the RNA delivery and liposomes, and metal oxide nanoparticles (MONPs) used for localised cancer treatment, gene therapy, vaccines (COVID-19) or as contrast agents. By providing fit for purpose methodologies, standardised methods and CRMs to regulators and industrial stakeholders, the project will support 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.

Kategorie

Text

Abstract
(Englisch)

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. This project responds to the immediate metrological needs expressed by industry, regulatory agencies and policymakers to develop and validate traceable measurement methods and candidate reference materials (CRMs) for the assessment of the critical quality attributes (CQAs) of nanotherapeutics. The project will focus on clinical formulations, including synthetic lipid-based nanotherapeutics, including lipid nanoparticles (LNPs) for the RNA delivery and liposomes, and metal oxide nanoparticles (MONPs) used for localised cancer treatment, gene therapy, vaccines (COVID-19) or as contrast agents. By providing fit for purpose methodologies, standardised methods and CRMs to regulators and industrial stakeholders, the project will support 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.