Ghent University and CellGENTherapies, the GMP facility of Ghent University hospital, are key partner in ATMP XB, a cross-border initiative between Flanders and the Netherlands. The aim is to accelerate the development, production, and quality control of Advanced Therapy Medicinal Products (ATMPs).
ATMP XB includes:
- strengthening the infrastructure for RNA-based processes and installation of related training
- the creation of a cross-border QA/QC Competence Centre
- the development of real-time process monitoring technologies and a new device enabling safe intradermal administration of cell therapies.
The goal is a learning network to address process development of new ATMPs, hands-on training of analysts and operators, and support biotech’s & academic partners in the region, which want to scale up their RNA- or cell-based therapies.
Within this project, Ghent University will establish new infrastructure for process development and training in manufacturing of RNA-based ATMPs, supported by the experienced GMP-qualified team of CellGENTherapies.
With ATMP XB, we will contribute to a unique ecosystem for ATMPs that brings innovation, training, and clinical translation closer together. Our new facility to be in operation in 2027 is designed to support hands-on training. It includes a training lab and a system of mobile equipment that can be easily rolled in and out of the training lab.
Prof Bart Vandekerckhove, Dir CellGENTherapies
Research profile for Bart Vandekerckhove – CRIG profile
ATMP XB comprises
Extensive training program for well-trained analysts and operators:
The setup of a course on RNA-based production processes (Ghent University & CellGENTherapies), a postgraduate course in analytical techniques for ATMPs (Karel de Grote University College) and an ATMP immersion workshop (KU Leuven & UCB).
Flemish-Dutch QA/QC Competence Centre
One of ATMP XB’s priorities is the establishment of a cross-border QA/QC Competence Centre at the science park in Niel. This unique facility will be able to carry out the three critical ATMP quality tests – mycoplasma, endotoxins, and sterility.
Two innovation projects
Real-time process monitoring during ATMP production.
Dutch high-tech partners are developing an innovative technology that allows the quality of cell therapy to be monitored in real time during production, which is a major breakthrough for personalised, autologous therapies.
New device technology for safe, efficient administration
Flemish partners are developing an intradermal injection device that can be directly linked to cryopreserved cells, supplemented with advanced genetic quality analyses based on long-read sequencing. Ghent University provides expertise that makes these innovations usable in a GMP context. ATMP XB is an Interreg Flanders-Netherlands project with a total budget of €4.52 million, of which €2.24 million is ERDF support. The consortium comprises more than 15 partners from Flanders and the Netherlands, including Ghent University, KU Leuven, Karel de Grote Hogeschool, at.las, Medvia, anicells, Idevax, QbD, Sure Laboratories, Unitron, Voxdale and OHMX.bio.