“Quality-Controlled Small-Scale Production of a Well-Defined Bacteriophage Cocktail for Use in Human Clinical Trials”
This scientific work points out all steps(*) for producing a Bacteriophage Cocktail used for the treatment of Pseudomonas aeruginosa and Staphylococcus aureus infections in burn wound patients.
-*Titration of bacteriophage suspensions using the agar overlay method
-*Initial isolation, separation and purification of P. aeruginosa and S. aureus lytic bacteriophages
-*Production of bacteriophage stocks
-*Selection of therapeutic bacteriophages
-*Composition and endotoxin purification of the bacteriophage cocktail
-*Final quality control
-*Pyrogenicity
-*Sterility
-Transmission electron microscopy
-*Exclusion of temperate bacteriophages from the host strains
-*Genome sequencing and proteomic analysis
-*Cytotoxicity towards keratinocytes
-*Stability at 4°C
-*Stability after spraying
-*Batch record file
-*Clinical application
