Metrology for innovative nanotherapeutics

欧洲正面临着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增加所带来的重大医疗挑战。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治疗（这里定义为纳米治疗）对于应对健康和社会挑战至关重要，提供了多功能的技术解决方案。该项目响应了行业，监管机构和政策制定者表达的迫切需求，以开发和验证可追溯的测量方法和候选参考材料（CRM），用于评估纳米治疗药物的关键质量属性（CQA）。该项目将专注于临床制剂，包括合成脂质纳米治疗剂，包括用于RNA递送和脂质体的脂质纳米颗粒（LNP），以及用于局部癌症治疗，基因治疗，疫苗（COVID-19）或造影剂的金属氧化物纳米颗粒（MONP）。通过向监管机构和行业利益相关者提供适合目的的方法，标准化方法和CRM，该项目将支持其临床转化，提供更有效的纳米治疗药物，副作用更少，以改善患者的生活质量，并提高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.