CellGENTherapies specialises in the production of advanced gene, cell and tissue therapies (ATMPs) for early-stage clinical trials in accordance with good manufacturing practices (GMP). The facility produces, amongst other things, lipid nanoparticles encapsulating mRNA, CAR T cells, dendritic cells and virus-specific T cells.
CellGENTherapies’ mission is to bring research from academic and industrial partners ‘from bench to bedside’ by offering small-scale production and quality controls in accordance with GMP, for both off-the-shelf and personalised therapeutics. In addition to production and quality controls, CellGENTherapies also offers services such as drafting the IMPD.
Services
- Technology transfer: translation of research-grade production processes into GMP-grade production processes
- Production, quality control and release of investigational ATMPs
- Preparation of the Investigational Medicinal Product Dossier (IMPD)