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| Consensus on Standards of Phage Quality for Prophylactic and Therapeutic Use |
Phage Research Alliance Chinese, Medical Microbiology and Immunology Committee of Chinese Society for Microbiology, Phage Technology Committee of Chinese Society of Biotechnology,Jinhong Writers: QIN1,**( ),Xiaokui GUO2,**(),Nannan WU3,**(),Yigang TONG4,**() |
1 Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
2 School of Global Health, Chinese Center for Tropical Diseases Research, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
3 CreatiPhage Biotechnology Co., Ltd., Shanghai 201108, China
4 College of Life Science and Technology, Beijing University of Chemical Technology, Beijing 100029, China |
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Abstract The emergence of drug resistant pathogens has posed a major challenge to global public health. Phage therapy, as an alternative therapy for the treatment of bacterial infections, has received renewed attention from clinicians, researchers and industrialists in recent years. Phages are a kind of viruses that specifically infect bacteria. Phage therapy can precisely target and eliminate pathogens without harming the natural environment or human microbiota. Due to the characteristics of phages such as live virus property and bactericidal specificity, the pharmacological, non-clinical and clinical studies of phages are different from those of traditional drugs. Currently, there is still a lack of relevant standards and guidelines worldwide, which has severely limited the translational application of phages and their products. To this end, based on the experience of clinical studies on phage therapy in the early stage, and referring to the literature reports on phage therapy, we organized experts including researchers, clinicians, and pharmacologists to draft this consensus. Requirements for phage source, phage host, biological properties of phages, and packaging and labelling of phages are proposed. The aim is to standardize the standards for phage applications and to meet the needs of phage library sharing, so as to accelerate the research, translation and application of phages.
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Received: 25 October 2023
Published: 04 February 2024
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