Metrology to support sustainable development of nanomedicines for therapy and theranostics

Chronic diseases, such as cancer, account for 85 % of healthcare costs across the EU and, compounded by aging populations, are predicted to be responsible for more than 80 % of global deaths by 2030. The United Nations 2030 Agenda for Sustainable Development has recognised chronic diseases as a major challenge for sustainable development and world governments have commit to achieving a 30 % reduction in premature mortality from chronic diseased by 2030 through improved prevention and treatment. Nanomedicine has a key role to play in reaching this goal, providing targeted delivery, reduced side effects and improved cost effectiveness versus conventional therapies. Currently, over 50 nanotherapeutic formulations are commercially available and over 400 are estimated to be in clinical trials. However, approximately 90 % of these will fail, in many cases due to poor understanding of aspects such as drug concentration, impurities, and drug stability. To reduce this failure rate and improve the efficacy of nanomedicines, new methods to quantify these key factors are needed.

This project will develop validated, harmonised and traceable methods to support the safe and sustainable development of nanomedicines. This includes representative test materials for different classes of nanomedicines, characterised by particle size, number concentration and drug load. In vitro methods for simulated drug release and post-release potency assessment will be validated to reduce clinical trial failure and improve safety, alongside ultra-fast measurement methods and AI models to monitor and control manufacturing.

This work will help to ensure effective, safe nanomedicines can succeed through clinical trials and become a more widely available therapy to treat chronic diseases.