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Quality and safety requirements for sustainable phage therapy products.

Jean-Paul Pirnay 1, * Bob G Blasdel 2 Laurent Bretaudeau 3 Angus Buckling 4 Nina Chanishvili 5 Jason R Clark 6 Sofia Corte-Real 7 Laurent Debarbieux 8 Alain Dublanchet 9 Daniel de Vos 1 Jérôme Gabard 10 Miguel Garcia 7 Marina Goderdzishvili 5 Andrzej Górski 11, 12 John Hardcastle 6 Isabelle Huys 13 Elizabeth Kutter 14 Rob Lavigne 2 Maia Merabishvili 15, 1, 5 Ewa Olchawa 16 Kaarle J Parikka 17, 18 Olivier Patey 9 Flavie Pouilot 10 Gregory Resch 19 Christine Rohde 20 Jacques Scheres 21, 22 Mikael Skurnik 23, 24 Mario Vaneechoutte 15 Luc van Parys 25 Gilbert Verbeken 1 Martin Zizi 18, 17 Guy van den Eede 26
* Corresponding author
1 Laboratory for Molecular and Cellular Technology
2 Laboratory of Gene Technology
3 Clean Cells
4 Department of Biosciences [Penryn]
5 George Eliava Institute of Bacteriophages, Microbiology and Virology [Tbilisi, Georgia]
6 Novolytics Limited [Warrington]
7 TechnoPhage [Lisbon]
8 BMGE - Biologie Moléculaire du Gène chez les Extrêmophiles
9 Service de Médecine Interne, Maladies Infectieuses et Tropicales [Villeneuve-Saint-Georges]
10 Pherecydes Pharma
11 Medical University of Warsaw - Poland
12 Institute of Immunology and Experimental Therapy
13 Clinical Pharmacology and Pharmacotherapy [Leuven]
14 Evergreen State College
15 Laboratory for Bacteriology Research [Ghent]
16 Instytut Biotechnologii Surowic I Szczepionek Biomed
17 Department of Physiology [Brussel]
18 COMOPSMED - Belgian Defense Staff, Medical Operational Command
19 Department of Fundamental Microbiology [Lausanne]
20 Department of Microorganisms [Braunschweig]
21 ECDC - European Centre for Disease Prevention and Control
22 National Institute of Public Health
23 Haartman Institute [Helsinki]
24 Laboratory diagnostics
25 5 EMI - 5th Element of Medical Intervention [Belgium]
26 European Commission - Joint Research Centre
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.
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Jean-Paul Pirnay, Bob G Blasdel, Laurent Bretaudeau, Angus Buckling, Nina Chanishvili, et al.. Quality and safety requirements for sustainable phage therapy products.. Pharmaceutical Research, American Association of Pharmaceutical Scientists, 2015, 32 (7), pp.2173-9. ⟨10.1007/s11095-014-1617-7⟩. ⟨pasteur-01539084⟩

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