Clinical phages and legal regulation

The Clinical Phages and Legal Regulation department at DSMZ bridges biological resource management, phage research and regulatory science to support the safe and effective implementation of phage-based approaches. Central to the department is the DSMZ Phage Collection, which preserves, authenticates and distributes bacteriophages and their bacterial hosts while generating the scientific and regulatory knowledge required for their responsible use.

The department develops and applies standardized workflows for phage isolation, characterization, taxonomy, host-range determination, quality control, long-term preservation and data curation. In parallel, it contributes to the development of quality standards, regulatory frameworks and best practices that support the clinical translation and broader implementation of phage-based approaches.

Bacteriophages have applications extending beyond human medicine, encompassing also veterinary, food and environmental sectors. Through national and international collaborations and regulatory engagement, DSMZ contributes to the establishment of a robust framework towards a reproducible and sustainable use of phages, safeguarding these unique biological resources for future research and innovation.