Department Trauma & Orthopedic Surgery, Septic & Reconstructive Surgery, Research and Treatment Center Septic Defect Wounds, Federal Armed Forces of Germany, Military Academic Hospital Berlin, Scharnhorststr. 13, 10115 Berlin, Germany
Joachim J. Bugert
Bundeswehr Institute of Microbiology, Neuherbergstr. 11, 80937 Munich, Germany
Annika Y. Classen
Department I for Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany
Li Deng
Institute of Virology, Helmholtz Centre Munich—German Research Centre for Environmental Health, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany
Anja Düchting
Unit for Pharmaceutical Biotechnology, Federal Institute for Drugs and Medical Devices (BfArM), Quality Inspections, 53175 Bonn, Germany
Justus Gross
Department of General, Visceral, Thoracic, Vascular and Transplant Surgery, University Medical Centre Rostock, 18057 Rostock, Germany
Jens A. Hammerl
Division Diagnostics, Pathogen Characterisation, Parasites in Food, Department Biological Safety, German Federal Institute for Risk Assessment (BfR), 12277 Berlin, Germany
Imke H. E. Korf
Department of Pharmaceutical Biotechnology, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 38124 Braunschweig, Germany
Christian Kühn
Department of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany
Simone Lieberknecht-Jouy
Department of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, 60596 Frankfurt am Main, Germany
Christine Rohde
Department Bioresources for Bioeconomy and Health Research, Leibniz Institute, DSMZ-German Collection of Microorganisms and Cell Cultures GmbH, 38124 Braunschweig, Germany
Markus Rupp
Department of Trauma Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany
Maria J. G. T. Vehreschild
German Center for Infection Research (DZIF), Partner Site Bonn-Cologne, 50931 Cologne, Germany
Kilian Vogele
Physics-Department and ZNN, Physics of Synthetic Biological Systems-E14, Technische Universität München, 85748 Garching, Germany
Sarah Wienecke
Department of Pharmaceutical Biotechnology, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 38124 Braunschweig, Germany
Martin Witzenrath
Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité—Universitätsmedizin Berlin, 10117 Berlin, Germany
Silvia Würstle
Department of Internal Medicine II, University Hospital Rechts der Isar, School of Medicine, Technical University of Munich, 81675 Munich, Germany
Holger Ziehr
Department of Pharmaceutical Biotechnology, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 38124 Braunschweig, Germany
Karin Moelling
Max Planck Institute for Molecular Genetics, Ihnestr. 63-73, 14195 Berlin, Germany
Bacteriophage therapy holds promise in addressing the antibiotic-resistance crisis, globally and in Germany. Here, we provide an overview of the current situation (2023) of applied phage therapy and supporting research in Germany. The authors, an interdisciplinary group working on patient-focused bacteriophage research, addressed phage production, phage banks, susceptibility testing, clinical application, ongoing translational research, the regulatory situation, and the network structure in Germany. They identified critical shortcomings including the lack of clinical trials, a paucity of appropriate regulation and a shortage of phages for clinical use. Phage therapy is currently being applied to a limited number of patients as individual treatment trials. There is presently only one site in Germany for large-scale good-manufacturing-practice (GMP) phage production, and one clinic carrying out permission-free production of medicinal products. Several phage banks exist, but due to varying institutional policies, exchange among them is limited. The number of phage research projects has remarkably increased in recent years, some of which are part of structured networks. There is a demand for the expansion of production capacities with defined quality standards, a structured registry of all treated patients and clear therapeutic guidelines. Furthermore, the medical field is still poorly informed about phage therapy. The current status of non-approval, however, may also be regarded as advantageous, as insufficiently restricted use of phage therapy without adequate scientific evidence for effectiveness and safety must be prevented. In close coordination with the regulatory authorities, it seems sensible to first allow some centers to treat patients following the Belgian model. There is an urgent need for targeted networking and funding, particularly of translational research, to help advance the clinical application of phages.
