Quality and safety requirements for sustainable phage therapy products.

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Version: Final published version
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Serval ID
serval:BIB_2CDEAF7F3438
Type
Article: article from journal or magazin.
Collection
Publications
Title
Quality and safety requirements for sustainable phage therapy products.
Journal
Pharmaceutical Research
Author(s)
Pirnay J.P., Blasdel B.G., Bretaudeau L., Buckling A., Chanishvili N., Clark J.R., 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 K.J., 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.
ISSN
1573-904X (Electronic)
ISSN-L
0724-8741
Publication state
Published
Issued date
2015
Volume
32
Number
7
Pages
2173-2179
Language
english
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.
Pubmed
Web of science
Open Access
Yes
Create date
29/06/2015 13:23
Last modification date
20/08/2019 14:11
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