Phage therapy is currently going through a renaissance and there are new phage therapy companies and academic centers being established all around the world. Phages are considered medicines by National drug regulatory agencies. Therefore, their production must fulfill good manufacturing practice (GMP) standards. The development of GMP standards for phage products requires validated methods accessible to different sized laboratories and companies. However, standardized processes for the entire pipeline of the production of phage-based drugs - i.e., phage collection, phage selection, purification, and quality controls (QC) - are still largely missing. Accordingly, there is a crucial need for comprehensive discussion between the different actors in the field to create the methods and standards that would enable phage therapy to become a clinical reality.
We wish this Research Topic to be an open forum for discussion about the standards and practices concerning the laboratory side (i.e., from phage collection to production) of personalized therapeutic phage products. Examples of questions that will be addressed are: How should we isolate and characterize therapeutic phages? How should we store a phage collection? How should we select the phage(s) that will be administered to patients? How should we select the best combination of phage(s)/antibiotic to administer to patients? How should we produce and purify phages in small or large batches for therapeutic purposes? What are the specifications phage products should fulfill to be successfully considered a therapeutic? What QC should we consider in the processing pipeline of developing a phage-based therapeutic product? What could be standardized (or not) in the pipeline from phage collection to phage production, including QC?
This Research Topic is dedicated to studies addressing the development of standards and methods that are or could be implemented in the production pipeline of phage-based drugs. We welcome Original Research articles, Mini-Reviews, Opinion papers, and Reviews under, but not limited to, the following themes:
• Development of bioinformatics tools for phage characterization
• Development of phage susceptibility assays and phagogram analyses
• Development of methods and standards for phage production and purification
• Development of methods and standards for associated QC
Phage therapy is currently going through a renaissance and there are new phage therapy companies and academic centers being established all around the world. Phages are considered medicines by National drug regulatory agencies. Therefore, their production must fulfill good manufacturing practice (GMP) standards. The development of GMP standards for phage products requires validated methods accessible to different sized laboratories and companies. However, standardized processes for the entire pipeline of the production of phage-based drugs - i.e., phage collection, phage selection, purification, and quality controls (QC) - are still largely missing. Accordingly, there is a crucial need for comprehensive discussion between the different actors in the field to create the methods and standards that would enable phage therapy to become a clinical reality.
We wish this Research Topic to be an open forum for discussion about the standards and practices concerning the laboratory side (i.e., from phage collection to production) of personalized therapeutic phage products. Examples of questions that will be addressed are: How should we isolate and characterize therapeutic phages? How should we store a phage collection? How should we select the phage(s) that will be administered to patients? How should we select the best combination of phage(s)/antibiotic to administer to patients? How should we produce and purify phages in small or large batches for therapeutic purposes? What are the specifications phage products should fulfill to be successfully considered a therapeutic? What QC should we consider in the processing pipeline of developing a phage-based therapeutic product? What could be standardized (or not) in the pipeline from phage collection to phage production, including QC?
This Research Topic is dedicated to studies addressing the development of standards and methods that are or could be implemented in the production pipeline of phage-based drugs. We welcome Original Research articles, Mini-Reviews, Opinion papers, and Reviews under, but not limited to, the following themes:
• Development of bioinformatics tools for phage characterization
• Development of phage susceptibility assays and phagogram analyses
• Development of methods and standards for phage production and purification
• Development of methods and standards for associated QC
