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Quality and safety requirements for sustainable phage therapy products

(2015) PHARMACEUTICAL RESEARCH. 32(7). p.2173-2179
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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 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.
Keywords
antibiotic resistance, medicinal product, phage therapy, production, quality and safety, PSEUDOMONAS-AERUGINOSA, GENE-TRANSFER, AGENTS

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MLA
Pirnay, Jean-Paul et al. “Quality and Safety Requirements for Sustainable Phage Therapy Products.” PHARMACEUTICAL RESEARCH 32.7 (2015): 2173–2179. Print.
APA
Pirnay, J.-P., Blasdel, B. G., Bretaudeau, L., Buckling, A., Chanishvili, N., Clark, J. R., Corte-Real, S., et al. (2015). Quality and safety requirements for sustainable phage therapy products. PHARMACEUTICAL RESEARCH, 32(7), 2173–2179.
Chicago author-date
Pirnay, Jean-Paul, Bob G. Blasdel, Laurent Bretaudeau, Angus Buckling, Nina Chanishvili, Jason R. Clark, Sofia Corte-Real, et al. 2015. “Quality and Safety Requirements for Sustainable Phage Therapy Products.” Pharmaceutical Research 32 (7): 2173–2179.
Chicago author-date (all authors)
Pirnay, Jean-Paul, Bob G. Blasdel, Laurent Bretaudeau, Angus Buckling, Nina Chanishvili, Jason R. Clark, Sofia Corte-Real, Laurent Debarbieux, Alain Dublanchet, Daniel De Vos, Jérôme Gabard, Miguel Garcia, Marina Goderdzishvili, Andrzej Górski, John Hardcastle, Isabelle Huys, Elizabeth Kutter, Rob Lavigne, Maia Merabishvili, Ewa Olchawa, Kaarle J. Parikka, Olivier Patey, Flavie Pouilot, Gregory Resch, Christine Rohde, Jacques Scheres, Mikael Skurnik, Mario Vaneechoutte, Luc Van Parys, Gilbert Verbeken, Martin Zizi, and Guy Van den Eede. 2015. “Quality and Safety Requirements for Sustainable Phage Therapy Products.” Pharmaceutical Research 32 (7): 2173–2179.
Vancouver
1.
Pirnay J-P, Blasdel BG, Bretaudeau L, Buckling A, Chanishvili N, Clark JR, et al. Quality and safety requirements for sustainable phage therapy products. PHARMACEUTICAL RESEARCH. 2015;32(7):2173–9.
IEEE
[1]
J.-P. Pirnay et al., “Quality and safety requirements for sustainable phage therapy products,” PHARMACEUTICAL RESEARCH, vol. 32, no. 7, pp. 2173–2179, 2015.
@article{8516220,
  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 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.},
  author       = {Pirnay, Jean-Paul and Blasdel, Bob G. and Bretaudeau, Laurent and Buckling, Angus and Chanishvili, Nina and Clark, Jason R. and Corte-Real, Sofia and Debarbieux, Laurent and Dublanchet, Alain and De Vos, Daniel and Gabard, Jérôme and Garcia, Miguel and Goderdzishvili, Marina and Górski, Andrzej and Hardcastle, John and Huys, Isabelle and Kutter, Elizabeth and Lavigne, Rob and Merabishvili, Maia and Olchawa, Ewa and Parikka, Kaarle J. and Patey, Olivier and Pouilot, Flavie and Resch, Gregory and Rohde, Christine and Scheres, Jacques and Skurnik, Mikael and Vaneechoutte, Mario and Van Parys, Luc and Verbeken, Gilbert and Zizi, Martin and Van den Eede, Guy},
  issn         = {0724-8741},
  journal      = {PHARMACEUTICAL RESEARCH},
  keywords     = {antibiotic resistance,medicinal product,phage therapy,production,quality and safety,PSEUDOMONAS-AERUGINOSA,GENE-TRANSFER,AGENTS},
  language     = {eng},
  number       = {7},
  pages        = {2173--2179},
  title        = {Quality and safety requirements for sustainable phage therapy products},
  url          = {http://dx.doi.org/10.1007/s11095-014-1617-7},
  volume       = {32},
  year         = {2015},
}

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