Innovating Works

EXPERT

Financiado
EXpanding Platforms for Efficacious mRNA Therapeutics
The overall objective of 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 mee... The overall objective of 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. As proof-of-concept we will perform a first-in-man clinical study for an intratumorally administered immunostimulatory mRNA-nanomedicine in cancer patients. 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. To address their complexity we 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 ver más
28/02/2025
UMC UTRECHT
15M€
Duración del proyecto: 67 meses Fecha Inicio: 2019-07-03
Fecha Fin: 2025-02-28

Línea de financiación: concedida

El organismo H2020 notifico la concesión del proyecto el día 2019-07-03
Línea de financiación objetivo El proyecto se financió a través de la siguiente ayuda:
SC1-BHC-09-2018: Innovation platforms for advanced therapies of the future
Cerrada hace 6 años
Presupuesto El presupuesto total del proyecto asciende a 15M€
Líder del proyecto
UNIVERSITAIR MEDISCH CENTRUM UTRECHT No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico TRL 4-5