From Experimental Use to Controlled Research
Although bacteriophages are already used sporadically in some countries, they are often applied outside established pharmaceutical infrastructures. Patients may travel abroad for treatment, while data on efficacy, dosing, and safety are only limitedly collected and analyzed. “At the moment, we are learning very little from these treatments,” says Roestenberg. “What we need is controlled clinical research to determine in which patients bacteriophages are effective and in which they are not.”
To achieve this, production according to strict pharmaceutical quality standards is essential. The INFECTORY project will therefore design and build an entirely new GMP manufacturing facility. Wilfried Bakker, project manager of the initiative, explains that this involves much more than simply installing equipment.
“You need a controlled production environment where you can safely work with microorganisms and genetically modified bacteria,” says Bakker. “This requires specialized manufacturing and analytical equipment, process and analytical validation, protocols, regulatory approvals, and extensive quality controls. Everything must be fully traceable.” In the final phase of the project, the consortium aims to produce multiple batches of bacteriophages annually for use in clinical studies.
New Opportunities for Complex Infections
The societal relevance of the project is significant. Existing treatments often fall short for complex infections, such as those associated with implants or other foreign materials in the body. Antibiotics may not effectively reach these infections, while the immune system also struggles to eliminate bacteria in such environments. “Bacteriophages may prove particularly valuable for these types of infections,” says bacteriophage expert Pieter Jan Haas of the UMCU. “But we will only know that once we investigate it systematically. This project makes that possible.”
The infrastructure developed within the project is also intended to be broadly applicable. Once the production process is established, other bacteriophages can in principle be produced for different bacterial infections. This creates a flexible platform capable of accelerating future innovation.
INFECTORY also aims to organize production in an accessible and scalable way. The facility will manufacture bacteriophages on demand, reducing waste while providing researchers, hospitals, and companies with access to high-quality bacteriophages for research and clinical applications. Centralized storage and standardized production pathways are also being developed to ensure high quality while keeping costs manageable.
Public Investment as a Driver of Innovation
An important aspect of the project is that it operates at the intersection of societal need and economic risk. According to Saco de Visser, Scientific Director of FAST, this is precisely why public support is crucial.
“This is exactly the kind of development that the market is not yet ready to take on by itself,” he says. “The investments are substantial and the uncertainties considerable. Yet the societal need is enormous. Through this project, we aim to lower that initial barrier by building both evidence and infrastructure. Thanks in part to the support of the Future Affordable Sustainable Therapy initiative from our ministries, we can work together on projects of this importance.”
According to the consortium partners, the project is only feasible because each organization contributes complementary expertise, ranging from GMP manufacturing and regulatory affairs to clinical research and engineering. “No single organization can do this alone,” says Pauline Meij, Qualified Person at LUMC. “It is precisely the combination of knowledge, infrastructure, and collaboration that enables us to create something that goes beyond what any individual party could achieve.”
Through INFECTORY, the consortium aims not only to establish a new infrastructure, but also to demonstrate how public and private partners can jointly accelerate innovation in areas where societal impact is paramount. Tim van Schijndel, board member of AHAM Real Estate, explains: “AHAM is building a carefully selected portfolio of socially relevant real estate, with the goal of enabling projects whose impact extends far beyond the scale of the building itself. The collaboration with INFECTORY represents the culmination of that search and serves as a major source of motivation for our team.”
Antimicrobial resistance is widely regarded as one of the world’s most pressing medical challenges. By enabling the controlled development and production of bacteriophages, the project partners hope to contribute to new treatment options for complex infections where existing antibiotics are no longer sufficient.
More information?
For more information about INFECTORY, please contact Wilfried Bakker, Director INFECTORY, email: w.bakker@infecta.org or check the website: www.infecta.org
Text: PharmaNL (author Marlies Schipperheijn)
Photo The INFECTORY project team, from left to right: Pauline Meij (LUMC), Tim van Schijndel (AHAM), Meta Roestenberg (INFECTA), Wilfried Bakker (INFECTA), Saco de Visser (FAST), and Pieter-Jan Haas (UMC Utrecht). Group photo composed using ChatGPT by Sophie Watertor, Communications Lead at INFECTA.