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© Laurent Debarbieux
Bactériophages sur la bactérie Escherichia coli 0104:H4 souche 55989.
Publication : Pharmaceutical research

Quality and safety requirements for sustainable phage therapy products

Scientific Fields
Diseases
Organisms
Applications
Technique

Published in Pharmaceutical research - 14 Jan 2015

Pirnay JP, Blasdel BG, Bretaudeau L, Buckling A, Chanishvili N, Clark JR, Corte-Real S, Debarbieux L, Dublanchet A, De Vos D, Gabard J, Garcia M, Goderdzishvili M, Górski A, Hardcastle J, Huys I, Kutter E, Lavigne R, Merabishvili M, Olchawa E, Parikka KJ, Patey O, Pouilot F, Resch G, Rohde C, Scheres J, Skurnik M, Vaneechoutte M, Van Parys L, Verbeken G, Zizi M, Van den Eede G

Link to Pubmed [PMID] – 25585954

Pharm. Res. 2015 Jul;32(7):2173-9

The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In addition, phages have the capacity to rapidly overcome bacterial resistances, which will inevitably emerge. To maximally exploit these advantage phages have over conventional drugs such as antibiotics, it is important that sustainable phage products are not submitted to the conventional long medicinal product development and licensing pathway. There is a need for an adapted framework, including realistic production and quality and safety requirements, that allows a timely supplying of phage therapy products for ‘personalized therapy’ or for public health or medical emergencies. 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.

http://www.ncbi.nlm.nih.gov/pubmed/25585954