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"This paper enumerates all phage therapy product related quality and safety risks known to the authors, as well as the tests that can be performed to minimize these risks, only to the extent needed to protect the patients and to allow and advance responsible phage therapy and research".
" To avoid the mistakes of the past (which lead to the current antibiotic resistance crisis), phage therapy products should not exclusively be developed and marketed as antibiotics, i.e., applying current pharmacoeconomic principles. Ideally, phage therapy should be coordinated and standardized (in a first instance) by national phage therapy centers, which operate under the supervision of relevant public health authorities and in interaction with private stakeholders".
Expert Consensus Quality and Safety Requirements for Sustainable Phage Therapy Products:
A. Production environment
B. Production processes, equipment and materials
C. Quality Assurance and Quality Control (QA/QC) specifications
C.1. Host bacteria used in production (stock suspensions)
C.2. Bacteriophages (Master Seed lots)
C.3. Bacteriophages (Working Seed lots/Active Substances)C.4. Finished products
D. Shelf life of phage stock suspensions, working solutions and finished products (at recommended storage conditions)
E. Surveillance
