title: Quality and safety requirements for sustainable phage therapy products.
abstract: 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.
authors.affiliation: Laboratory for Molecular and Cellular Technology, Queen Astrid Military Hospital, Bruynstraat 1, 1120, Brussel, Belgium, jean-paul.pirnay@mil.be.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Pirnay
authors.forename: Bob G
authors.initials: BG
authors.lastname: Blasdel
authors.forename: Laurent
authors.initials: L
authors.lastname: Bretaudeau
authors.forename: Angus
authors.initials: A
authors.lastname: Buckling
authors.forename: Nina
authors.initials: N
authors.lastname: Chanishvili
authors.forename: Jason R
authors.initials: JR
authors.lastname: Clark
authors.forename: Sofia
authors.initials: S
authors.lastname: Corte-Real
authors.forename: Laurent
authors.initials: L
authors.lastname: Debarbieux
authors.forename: Alain
authors.initials: A
authors.lastname: Dublanchet
authors.forename: Daniel
authors.initials: D
authors.lastname: De Vos
authors.forename: Jérôme
authors.initials: J
authors.lastname: Gabard
authors.forename: Miguel
authors.initials: M
authors.lastname: Garcia
authors.forename: Marina
authors.initials: M
authors.lastname: Goderdzishvili
authors.forename: Andrzej
authors.initials: A
authors.lastname: Górski
authors.forename: John
authors.initials: J
authors.lastname: Hardcastle
authors.forename: Isabelle
authors.initials: I
authors.lastname: Huys
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Kutter
authors.forename: Rob
authors.initials: R
authors.lastname: Lavigne
authors.forename: Maia
authors.initials: M
authors.lastname: Merabishvili
authors.forename: Ewa
authors.initials: E
authors.lastname: Olchawa
authors.forename: Kaarle J
authors.initials: KJ
authors.lastname: Parikka
authors.forename: Olivier
authors.initials: O
authors.lastname: Patey
authors.forename: Flavie
authors.initials: F
authors.lastname: Pouilot
authors.forename: Gregory
authors.initials: G
authors.lastname: Resch
authors.forename: Christine
authors.initials: C
authors.lastname: Rohde
authors.forename: Jacques
authors.initials: J
authors.lastname: Scheres
authors.forename: Mikael
authors.initials: M
authors.lastname: Skurnik
authors.forename: Mario
authors.initials: M
authors.lastname: Vaneechoutte
authors.forename: Luc
authors.initials: L
authors.lastname: Van Parys
authors.forename: Gilbert
authors.initials: G
authors.lastname: Verbeken
authors.forename: Martin
authors.initials: M
authors.lastname: Zizi
authors.forename: Guy
authors.initials: G
authors.lastname: Van den Eede
mesh_terms: D001424:Bacterial Infections / Q000382:microbiology / Q000628:therapy; D001435:Bacteriophages / Q000254:growth & development* / Q000302:isolation & purification; D001691:Biological Therapy / Q000009:adverse effects / Q000592:standards / Q000639:trends; D024901:Drug Resistance, Multiple, Bacterial; D006801:Humans