Nanomedicine represents a transformative frontier in healthcare, offering innovative solutions for diagnosis and treatment. However, this emerging field faces unique challenges. Key among these is the need for precise and reliable measurement methods to assess the quality of nanomedicines. The METRINO project arose from this necessity, driven by Europe's growing demand for accurate, consistent, and safe nanomedical applications.
The Essential Needs METRINO Addresses
Recognizing the potential of nanomedicines to address complex health challenges, METRINO focuses on developing standardised methods and reference materials for their characterization. This is crucial for regulatory compliance and ensuring the efficacy and safety of these advanced therapies. We address the needs identified by industry experts and regulatory bodies, ensuring that our efforts align with real-world requirements and future directions in healthcare.
Recognising the importance of nanomedicine: Healthcare challenges in Europe driven by an ageing population coupled with an increase in chronic diseases like cancer, diabetes, heart disease, and brain conditions could be addressed by innovative nanotherapeutics.
The clinical translation of nanomedicines depends on the availability of methods and reference materials to characterise those products according to the FDA, EMA and pharmacopoeia norms and guidelines.
The European Medical Agency (EMA) requires “new testing methods for quality and safety assessment of nanomedicines” that would allow for understanding the product complexity, and in particular the relationship between their physical-chemical properties, their biological activity and the in-vivo behaviour of the product”.
What are the specific methodological challenges? Previous european projects has identified specific needs for method development and standardisation in five areas of characterisation, including: (i) surface properties, (ii) drug loading and release, (iii) kinetic properties in complex biological media, (iv) ADME (absorption, distribution, metabolism and excretion) parameters and (v) interaction with blood and the immune system.
What the industrial community says about the needs?
A company developing contrast agents based on iron oxide and gadolinium- nanoparticles, states «the need for understanding the definition of particle size; feasibility, and improved methodologies to determine amount, homogeneity, and functionalization of the nanoparticle surface and for the functionality and detection of nanoparticles in vivo».
Developing liposome-based nanotherapeutics), highlighted «the lack of standardised methods to ensure the integrity of lipid-based products, to characterise their physico-chemical properties, and their behaviour in complex biological medium» and the need «to follow nanoparticle biodistribution and bio-transformation in vivo».
A global company designing clinically approved radio-enhancers for the treatment of soft tissue sarcoma, based on hafnium oxide nanoparticles-, underlines the critical «absence of reference materials and standardised methods for metal oxide nanoparticles» that are needed «for method validation of fit-for–purpose characterisation techniques following regulatory agency recommendations».
Why is METRINO unique and has a chance to work?
What sets METRINO apart is our comprehensive approach to tackling the multifaceted challenges of nanomedicine metrology. We're not just developing methods; we're shaping an ecosystem where nanomedicines can be reliably developed, evaluated, and brought to market faster and more safely. Our consortium's diverse expertise and collaborative approach enable us to create solutions that are robust, industry-relevant, and geared towards accelerating the adoption of nanomedicines in clinical practice. METRINO is uniquely positioned to make a significant difference in the field, advancing both the science of measurement and the future of patient care.
Shaping the Future of Nanomedicine Together
As we move forward, METRINO is committed to addressing the critical needs of the nanomedicine sector. Our work lays the foundation for a new era of healthcare innovation, where nanomedicines are not only visionary but also verified, trustworthy, and effective. Join us in this exciting journey as we redefine the boundaries of medicine and metrology.
