A new €14 million Advanced Therapy Medicinal Products (ATMP) production facility is being established at the Gasthuisberg campus in Leuven, Belgium, through a collaboration between KU Leuven and UZ Leuven. The facility, which received substantial funding from the Leuven Future Fund and Opening the Future initiative, aims to bridge the gap between translational research and clinical applications for cell and gene therapies.
The project, which began in June 2024, is currently in the final design stage of construction, which includes refurbishing an existing cleanroom. Both the facility and its specialized team are expected to be fully operational by the end of 2025.
Dual Mission: Translation and Production
According to Bart Geers, investment manager at LRD (KU Leuven Research & Development) and operational manager of the facility, the initiative has two primary objectives.
"On the one hand we're investing in a translational expertise centre to assist researchers in translating scientific research into clinical impact. On the other, we're investing in infrastructure by building a GMP facility to produce personalised cell therapies in-house in the hospital," Geers explained.
The facility will focus on developing personalized treatments such as modified T-cell therapies, where a patient's own leukocytes are extracted and engineered with cancer antigens using viral vectors to target specific forms of leukemia.
Building a Specialized Team
Recruitment is already underway for a specialized team that will initially consist of five members, with plans to expand to approximately ten employees. The facility is seeking professionals with expertise in preclinical development, health economics, management, Chemistry, Manufacturing & Controls (CMC) guidelines, and Good Manufacturing Practice (GMP).
"We're committed to maintaining the highest safety standards throughout our operations," Geers emphasized.
Focus on Rare Diseases and Underserved Patient Populations
A key differentiator for the academic-led facility is its commitment to addressing rare diseases and smaller patient populations that may be overlooked by commercial pharmaceutical companies due to limited profit potential.
"Pharmaceutical companies are very picky: they always balance cost and economic return. We make the case that, as an academic institution, we will also pay attention to rare diseases and small patient groups. All this from the social interest," said Geers.
Current Pipeline Projects
The facility plans to continuously manage approximately five active projects, either internally developed or in collaboration with external partners. Current projects in development include:
- A gene therapy for a rare pediatric disease in collaboration with a Swiss biotech company
- A proprietary form of CAR-T cell therapy for leukemia
- A cancer vaccine targeting glioblastoma
Cost-Effective Development Model
One of the most significant advantages of the academic-led facility is its ability to develop therapies at a fraction of the cost typically required by pharmaceutical companies.
"Because we are keeping our expertise and production processes within the public domain, we should be able to count on government support and grants, and do development at a lower cost," Geers explained. "We're counting on some 5 million euros to get a product in the clinic – a pharmaceutical company needs five to ten times more for that."
Accelerated Clinical Impact
The facility is strategically focusing on projects that can be translated into clinical studies relatively quickly. Geers noted that gene therapies often demonstrate rapid efficacy when successful, which can streamline the clinical trial process.
"When gene therapy works, that positive result is often seen quickly, which of course makes the clinical trial less expensive. And you won't need as many test patients," he said.
Cell therapies have already shown remarkable success in some cases, with patients experiencing complete recovery. "The potential impact of this type of treatment is very high and easily measurable," Geers added.
In-House Benefits for Patients and Physicians
By establishing an in-house ATMP facility, UZ Leuven will be able to modify patients' immune cells on-site, providing significant advantages for both doctors and patients. This capability is particularly valuable for treating diseases caused by genetic mutations or the absence of specific functional genes.
The facility is open to collaborations with interested parties, with Geers concluding, "Everyone interested in collaborating is welcome: the ATMP facility is open for business!"
