Introduction: The increasing shortage of human organ donors worldwide demands innovative solutions. Xenotransplantation - the transplantation of organs from animal donors into humans - has emerged as a promising approach. While initial procedures have already been performed in humans in the USA, their implementation in Germany faces complex legal requirements. This work explores the legal framework and practical requirements for establishing a designated pathogen free (DPF)-Unit in Germany as a key structural and regulatory solution to enable safe xenogeneic organ donation.
Methods: A legal and procedural analysis was performed to assess the requirements for xenotransplantation in Germany, with special focus on animal husbandry, the use of genetically modified organisms (GMOs), and their integration into the production of Advanced Therapy Medicinal Products (ATMPs). Relevant frameworks include the German Animal Welfare Act (TierschG), Genetic Engineering Safety Ordinance (GenTSV), Transplantation Act (TPG), the Medicinal Products Act (AMG) and its derived requirements for EU-GMP (Good Manufacturing Practice). International guidance and scientific best practices were also reviewed.
Results: Establishing a DPF-Unit in Germany interfaces multiple legal frameworks. However, if these frameworks are addressed and implemented to their fullest, a DPF-Unit provides a pragmatic solution by embedding secure animal housing and controlled organ explantation into the production process. This includes the housing of transgenic piglets under biosafety level 2 conditions from pre-born stage, minimizing pathogen exposure and transport-related risks. Dedicated equipment, hygienic procedures, and staff expertise ensure the absence of designated pathogens. Cardiac extractions can be conducted on-site and delivered directly to clinical facilities, fulfilling EU-GMP Part IV requirements and enhancing patient safety while complying with ethical and environmental standards.
Conclusion: This work proposes the DPF-Unit as a central structural element for enabling xenotransplantation under current legal frameworks and offers a possible roadmap for establishing a DPF-Unit in Germany. By providing conditions that meet both animal welfare requirements and EU-GMP Part IV standards for organ extraction, the DPF-Unit serves as a reliable environment for the generation of safe donor animals and high-quality xenogeneic organs, thereby contributing substantially to overall patient safety.