Phage Therapy in Germany—Update 2023
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 ba...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-02-01
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| Series: | Viruses |
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| Online Access: | https://www.mdpi.com/1999-4915/15/2/588 |
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| author | Christian Willy Joachim J. Bugert Annika Y. Classen Li Deng Anja Düchting Justus Gross Jens A. Hammerl Imke H. E. Korf Christian Kühn Simone Lieberknecht-Jouy Christine Rohde Markus Rupp Maria J. G. T. Vehreschild Kilian Vogele Sarah Wienecke Martin Witzenrath Silvia Würstle Holger Ziehr Karin Moelling Felix Broecker |
| author_facet | Christian Willy Joachim J. Bugert Annika Y. Classen Li Deng Anja Düchting Justus Gross Jens A. Hammerl Imke H. E. Korf Christian Kühn Simone Lieberknecht-Jouy Christine Rohde Markus Rupp Maria J. G. T. Vehreschild Kilian Vogele Sarah Wienecke Martin Witzenrath Silvia Würstle Holger Ziehr Karin Moelling Felix Broecker |
| author_sort | Christian Willy |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T08:00:15Z |
| format | Article |
| id | doaj.art-f28fe83aafa34f0aaeb86b8c94bc7cc1 |
| institution | Directory Open Access Journal |
| issn | 1999-4915 |
| language | English |
| last_indexed | 2024-03-11T08:00:15Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj.art-f28fe83aafa34f0aaeb86b8c94bc7cc12023-11-16T23:51:03ZengMDPI AGViruses1999-49152023-02-0115258810.3390/v15020588Phage Therapy in Germany—Update 2023Christian Willy0Joachim J. Bugert1Annika Y. Classen2Li Deng3Anja Düchting4Justus Gross5Jens A. Hammerl6Imke H. E. Korf7Christian Kühn8Simone Lieberknecht-Jouy9Christine Rohde10Markus Rupp11Maria J. G. T. Vehreschild12Kilian Vogele13Sarah Wienecke14Martin Witzenrath15Silvia Würstle16Holger Ziehr17Karin Moelling18Felix Broecker19Department 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, GermanyBundeswehr Institute of Microbiology, Neuherbergstr. 11, 80937 Munich, GermanyDepartment I for Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, GermanyInstitute of Virology, Helmholtz Centre Munich—German Research Centre for Environmental Health, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyUnit for Pharmaceutical Biotechnology, Federal Institute for Drugs and Medical Devices (BfArM), Quality Inspections, 53175 Bonn, GermanyDepartment of General, Visceral, Thoracic, Vascular and Transplant Surgery, University Medical Centre Rostock, 18057 Rostock, GermanyDivision Diagnostics, Pathogen Characterisation, Parasites in Food, Department Biological Safety, German Federal Institute for Risk Assessment (BfR), 12277 Berlin, GermanyDepartment of Pharmaceutical Biotechnology, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 38124 Braunschweig, GermanyDepartment of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, 30625 Hannover, GermanyDepartment of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, 60596 Frankfurt am Main, GermanyDepartment Bioresources for Bioeconomy and Health Research, Leibniz Institute, DSMZ-German Collection of Microorganisms and Cell Cultures GmbH, 38124 Braunschweig, GermanyDepartment of Trauma Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, GermanyGerman Center for Infection Research (DZIF), Partner Site Bonn-Cologne, 50931 Cologne, GermanyPhysics-Department and ZNN, Physics of Synthetic Biological Systems-E14, Technische Universität München, 85748 Garching, GermanyDepartment of Pharmaceutical Biotechnology, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 38124 Braunschweig, GermanyDepartment of Infectious Diseases, Respiratory Medicine and Critical Care, Charité—Universitätsmedizin Berlin, 10117 Berlin, GermanyDepartment of Internal Medicine II, University Hospital Rechts der Isar, School of Medicine, Technical University of Munich, 81675 Munich, GermanyDepartment of Pharmaceutical Biotechnology, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 38124 Braunschweig, GermanyMax Planck Institute for Molecular Genetics, Ihnestr. 63-73, 14195 Berlin, GermanyIdorsia (Berlin) Pharmaceuticals GmbH, Magnusstr. 11, 12489 Berlin, GermanyBacteriophage 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.https://www.mdpi.com/1999-4915/15/2/588phage therapyantimicrobial resistanceregulatory frameworkGermany |
| spellingShingle | Christian Willy Joachim J. Bugert Annika Y. Classen Li Deng Anja Düchting Justus Gross Jens A. Hammerl Imke H. E. Korf Christian Kühn Simone Lieberknecht-Jouy Christine Rohde Markus Rupp Maria J. G. T. Vehreschild Kilian Vogele Sarah Wienecke Martin Witzenrath Silvia Würstle Holger Ziehr Karin Moelling Felix Broecker Phage Therapy in Germany—Update 2023 Viruses phage therapy antimicrobial resistance regulatory framework Germany |
| title | Phage Therapy in Germany—Update 2023 |
| title_full | Phage Therapy in Germany—Update 2023 |
| title_fullStr | Phage Therapy in Germany—Update 2023 |
| title_full_unstemmed | Phage Therapy in Germany—Update 2023 |
| title_short | Phage Therapy in Germany—Update 2023 |
| title_sort | phage therapy in germany update 2023 |
| topic | phage therapy antimicrobial resistance regulatory framework Germany |
| url | https://www.mdpi.com/1999-4915/15/2/588 |
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