Project

Chromatography for the purification of in vitro transcribed RNA as part of the production process of lipid nanoparticle vaccines and cancer immunotherapeutics for use in clinical trials (C-puRNA)

Acronym
C-µRNA
Code
F2023/IOF-Equip/084
Duration
20 December 2023 → 19 December 2024
Funding
Regional and community funding: Industrial Research Fund
Research disciplines
  • Medical and health sciences
    • Vaccinology
Keywords
RNA vaccines lipid nanoparticles chromatography
 
Project description

The Cell and Gene therapy unit UZ Gent produces drugs based on cells and/or DNA/RNA for clinical trials. Recently, we focused on the development of the production process of RNA vaccines and RNA-based immunotherapeutics for cancer. We have an academic project in collaboration with the department of Pharmacy and Medical Genetics of the UGent, and VIB, as well as commercial collaborations. For the robust production of RNA-based medicinal products, impurities introduced during the RNA production step need to be eliminated, as these impurities may compromise the efficacy of the product. The removal of impurities is preferentially performed on a chromatograpy system. This system and the validation of the purification step is the subject of this application. By incorporating this purification step, we will be able to produce vaccines and RNA therapeutics with consistent efficacy. With this, it is our ambition to strengthen our position as an important player in the niche of early phase clinical trials and personalized medicine, which typically require the production of only small batches of the medicinal product.