CellGENTherapies
CellGEN Therapies produces advanced gene-, cell- and tissue-therapeutic products (ATMPs) for early phase clinical trials according to good manufacturing principles (GMP).
We focus on the development and production of small batches of ATMPs or RNA vaccines as required for personalized medicines or phase I studies. In this way, we preferentially interact with academic researchers as well as companies that have developed personalized ATMPs.
We help UZ Gent, external clients and partners to move their research “from bench to bedside” by providing the right expertise, equipment and a licensed facility for the production of small batches of cell and gene therapeutics.
About the GMP Unit
CellGENTherapies was founded in 2014. In 2016 the first ATMP was produced under GMP conditions. Ever since, the activity has been growing and other technologies became part of the portfolio. CellGENTherapies is currently licensed for the production of investigational advanced therapy medicinal products and will apply in 2024 for a license for the production of microbial vaccines.
To house the expanding activities, a new GMP unit will be constructed on the site of UZ Gent (Ghent University Hospital) and should be fully operational by mid 2025.
Our location on the campus of Ghent University Hospital ensures synergies with both the hospital and Ghent University. It also benefits from Ghent’s reputation as a leading cluster for biotech and medical companies, and its position as a gateway to Europe and the world.
Good Manufacturing Principles or GMP is a strict, tightly controlled framework with which a building and processes must comply. At the heart of the GMP is a sterile clean room with highly qualified persons that execute processes following strict guidelines. This is ensured by regular audits by the FAMHP.
Services
Technology transfer
We start from your research protocols and translate them towards GMP-compliant protocols. Additionally, Ghent University licenses technology in the field of gene and cell therapy.
Manufacturing of iATMP
We make products for clinical studies. We specialize in small and personalized batches, in a variety of technologies.
Writing of IMPDs
We write investigational medicinal product dossiers and interact with the regulatory body.
Quality testing
We have our own in-house quality laboratory and additionally work with recognized external analytical service providers.
Team
Bart Vandekerckhove
Head of the unit
Joline Ingels
Production unit
Saskia De Smet
Production unit
Viviane Van de Steene
Production unit
Bo Coppens
Production unit
Stijn De Munter
Production unit
Valerie Redant
Production unit
Nele Lootens
Quality assurance unit
Eva Van Houtte
Quality assurance unit
Ryma Addoun
Quality assurance unit
Louise De la Mane
Qualified person
Tim Desmet
Business development
Partners
Sponsors
