EXPERT Sep 2019 – Feb 2025
Project Details: Expanding Platforms for Efficacious mRNA Therapeutics.
Specific challenge: EXPERT is to create an off-the-shelf mRNA-delivering nanomedicine platform that is manufactured via a quality-by-design (QbD) approach with precise nanoparticle characterization and specifications that meet the requirements for GMP scaling up and clinical translation.
Scope: The work focuses on the three critical elements of the call “Innovation platforms for advanced therapies of the future” 1. EXPERT investigates mRNAs as therapeutics, which are classified as advanced therapies. 2. By showing proof-of-concept in a clinical trial we aim to meet the technical, industrial and regulatory challenges to develop a mRNA-nanomedicine formulation from bench to bedside. This opens up new treatment possibilities for a large group of cancer patients and paves the way for subsequent formulations strengthening the European advanced therapy R&D. 3. mRNA nanomedicines are a true platform technology. mRNAs are composed of four similar building blocks, resulting in a molecule with predictable qualities. This allows for a platform approach to production, purification, formulation and storage which streamlines the drug development process offering important technological progress in this field. We will encapsulate mRNA into nanocarriers. Thereby, the mRNA is protected and the physicochemical characteristics of the mRNA are overruled by the characteristics of the nanoparticle to enable target cell uptake. We have experience in state-of-the art materials to make mRNA nanomedicines.
Expected Impact: EXPERT will optimize nanoparticle design and manufacture via QbD. We will use microfluidic manufacture as a scalable and reproducible production technology. To characterize and manufacture the mRNA nanomedicines under GMP conditions we will use the EU-ecosystem of designated facilities within EUNCL and NANOP
INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials
- Overall budget € 15,010,087.50 (EU contribution €14,931,337.50)
TCD PI: Dr Adriele Prina-Mello, TTMI, School of Medicine
TCD budget: € 801,885.00
Weblink at European Commission portal: https://cordis.europa.eu/project/id/825828
Results and outcomes available at: https://cordis.europa.eu/project/id/825828/results