Quality and Safety Requirements for Sustainable Phage Therapy Products

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 allowsa 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

PIRNAY Jean-Paul;  BLASDEL Bob G.;  BRETAUDEAU Laurent;  BUCKLING Angus;  CHANISHVILI Nina;  CLARK Jason R.;  CORTE-REAL Sofia;  DEBARBIEUX Laurent;  DUBLANCHET Alain;  DE VOS Daniel;  GABARD Jerome;  GARCIA Miguel;  GODERDZISHVILI Marina;  GORSKI Andrzej;  HARDCASTLE John;  HUYS Isabelle;  KUTTER Elisabeth;  LAVIGNE Rob;  MERABISHVILI Maia;  OLCHAWA Ewa;  PARIKKA Kaarle J.;  PATEY Olivier;  POUILOT Flavie;  RESCH Gregory;  ROHDE Christine;  SCHERES Jacques;  SKURNIK Mikael;  VANEECHOUTTE Mario;  VAN PARYS Luc;  VERBEKEN Gilbert;  ZIZI Martin;  VAN DEN EEDE Guy; 

2019-02-08

SPRINGER/PLENUM PUBLISHERS

JRC94536

0724-8741,   

https://link.springer.com/article/10.1007%2Fs11095-014-1617-7,    https://publications.jrc.ec.europa.eu/repository/handle/JRC94536,   

10.1007/s11095-014-1617-7,