Metrology for innovative nanotherapeutics

欧洲正面临着巨大的医疗挑战，原因是人口老龄化，以及癌症、糖尿病、心脏病和脑部疾病等慢性疾病的增加。这些疾病需要多样化和复杂的治疗，这增加了医疗成本。纳米医学和纳米医疗设备疗法(这里定义为纳米疗法)对于应对健康和社会挑战至关重要，提供了多样化的技术解决方案。该项目回应了行业、监管机构和政策制定者表达的迫切计量需求，以开发和验证用于评估纳米疗法关键质量属性(CQA)的可追溯测量方法和候选参考材料(CRM)。该项目将专注于临床配方，包括基于合成脂质的纳米疗法，包括用于核糖核酸输送和脂质体的脂质纳米颗粒(LNPs)，以及用于局部癌症治疗、基因治疗、疫苗(新冠肺炎)或作为造影剂的金属氧化物纳米颗粒(MONPs)。通过向监管机构和行业利益相关者提供适合用途的方法学、标准化方法和标准物质管理，该项目将支持它们的临床翻译，提供更有效、副作用更少的纳米疗法，以改善患者的生活质量，并增强欧洲卫生技术行业的竞争力。

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.