Quality and safety requirements for sustainable phage therapy products

Pharmaceutical Research

Volumn 32, Issue 7, 2015, Pages 2173-2179

  Pirnay, Jean Paul ^a   Blasdel, Bob G ^b   Bretaudeau, Laurent ^c   Buckling, Angus ^d   Chanishvili, Nina ^e   Clark, Jason R ^f   Corte Real, Sofia ^g   Debarbieux, Laurent ^h   Dublanchet, Alain ⁱ   De Vos, Daniel ^a   Gabard, Jérôme ^j   Garcia, Miguel ^g   Goderdzishvili, Marina ^e   Górski, Andrzej ^k,l   Hardcastle, John ^f   Huys, Isabelle ^m   Kutter, Elizabeth ⁿ   Lavigne, Rob ^b   Merabishvili, Maia ^a,e,o   Olchawa, Ewa ^p   Parikka, Kaarle J ^q,r   Patey, Olivier ⁱ   Pouilot, Flavie ^j   Resch, Gregory ^s   Rohde, Christine ^t   Scheres, Jacques ^u,v   Skurnik, Mikael ^w,x   Vaneechoutte, Mario ^o   Van Parys, Luc ^g   Verbeken, Gilbert ^a   Zizi, Martin ^q,r   Van Den Eede, Guy ^y   more..

^a QUEEN ASTRID MILITARY HOSPITAL   (Belgium)

^b LABORATORY OF GENE TECHNOLOGY   (Belgium)

^c Parc d'Activités Vendee Sud Loire   (France)

^d UNIVERSITY OF EXETER   (United Kingdom)

^e George Eliava Institute of Bacteriophage Microbiology and Virology   (Georgia)

^f Novolytics Ltd   (United Kingdom)

^g TechnoPhage SA Edifício Egas Moniz ^*  (Belgium)

^h INSTITUT PASTEUR   (France)

ⁱ Centre Hospitalier Intercommunal de Villeneuve Saint Georges   (France)

^j Pherecydes Pharma   (France)

^k INSTITUTE OF IMMUNOLOGY AND EXPERIMENTAL THERAPY   (Poland)

^l MEDICAL UNIVERSITY OF WARSAW   (Poland)

^m DEPARTMENT OF PHARMACEUTICAL AND PHARMACOLOGICAL SCIENCES   (Belgium)

ⁿ EVERGREEN STATE COLLEGE   (United States)

^o GHENT UNIVERSITY   (Belgium)

^p Instytut Biotechnologii Surowic i Szczepionek Biomed S A   (Poland)

^q Belgian Defense Staff   (Belgium)

^r FREE UNIVERSITY OF BRUSSELS   (Belgium)

^s UNIVERSITY OF LAUSANNE   (Switzerland)

^t LEIBNIZ INSTITUTE DSMZ GERMAN COLLECTION OF MICROORGANISMS AND CELL CULTURES   (Germany)

^u NATIONAL MEDICINES INSTITUTE   (Poland)

^v EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL ECDC   (Sweden)

^w UNIVERSITY OF HELSINKI   (Finland)

^x HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^y JOINT RESEARCH CENTRE   (Italy)

more..

Author keywords

antibiotic resistance; medicinal product; phage therapy; production; quality and safety

Indexed keywords

ANTIBIOTIC RESISTANCE; BACTERIOPHAGE; FOOD POISONING; GOOD MANUFACTURING PRACTICE; HUMAN; LICENSING; PATENT; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; SAFETY; ADVERSE EFFECTS; BACTERIAL INFECTIONS; BIOLOGICAL THERAPY; GROWTH, DEVELOPMENT AND AGING; ISOLATION AND PURIFICATION; MICROBIOLOGY; MULTIDRUG RESISTANCE; STANDARDS; TRENDS;

BACTERIAL INFECTIONS; BACTERIOPHAGES; BIOLOGICAL THERAPY; DRUG RESISTANCE, MULTIPLE, BACTERIAL; HUMANS;

EID: 84930179600     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-014-1617-7     Document Type: Review

References (25)

1. Antimicrobial resistance: Global report on Surveillance. Geneva, World Health Organization (WHO), 2014. Available from: http://apps.who.int/iris/bitstream/10665/112642/1/9789241564748-eng.pdf?ua=1 (accessed 18/09/14).
2. Bush K, Courvalin P, Dantas G, Davies J, Eisenstein B, Huovinen P, et al. Tackling antibiotic resistance. Nat Rev Microbiol. 2011;9:894-6.
3. Borysowski J, Międzybrodzki R, Górski A. Phage therapy: current research and application. UK: Caister Academic Press; 2014.
4. Pirnay JP, De Vos D, Verbeken G, Merabishvili M, Chanishvili N, Vaneechoutte M, et al. The phage therapy paradigm: prêt-à-porter or sur-mesure? Pharm Res. 2011;28:934-7.
5. Merabishvili M, De Vos D, Verbeken G, Kropinski AM, Vandenheuvel D, Lavigne R, et al. Selection and characterization of a candidate therapeutic bacteriophage that lyses the Escherichia coli O104:H4 strain from the 2011 outbreak in Germany. PLoS ONE. 2012;7:e52709.
6. Hall AR, De Vos D, Friman VP, Pirnay JP, Buckling A. Effects of sequential and simultaneous applications of bacteriophages on populations of Pseudomonas aeruginosa in vitro and in wax moth larvae. Appl Environ Microbiol. 2012;78:5646-52.
7. Verbeken G, Pirnay JP, De Vos D, Jennes S, Zizi M, Lavigne R, et al. Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine. Arch Immunol Ther Exp (Warsz). 2012;60:161-72.
8. Seed KD, Yen M, Shapiro BJ, Hilaire IJ, Charles RC, Teng JE, et al. Evolutionary consequences of intra-patient phage predation on microbial populations. Elife. 2014;3:e03497.
9. Díaz-Muñoz SL, Koskella B. Bacteria-phage interactions in natural environments. Adv Appl Microbiol. 2014;89:135-83.
10. OECD. Best practice guidelines for biological resource centers - quality management, biosecurity, building capacity, preservation of biological resources, data management. Paris: Secretary-General of the OECD; 2007.
11. Lang AS, Zhaxybayeva O, Beatty JT. Gene transfer agents: phage-like elements of genetic exchange. Nat Rev Microbiol. 2012;10:472-82.
12. Christie GE, Dokland T. Pirates of the Caudovirales. Virology. 2012;434:210-21.
13. Burlage RS, Atlas R, Stahl D, Geesey G, Sayler G. Techniques in microbial ecology. USA: Oxford University Press; 1998.
14. Galán JC, Tato M, Baquero MR, Turrientes C, Baquero F, Martinez JL. Fosfomycin and rifampin disk diffusion tests for detection of Escherichia coli mutator strains. J Clin Microbiol. 2004;42:4310-2.
15. Merabishvili M, Verhelst R, Glonti T, Chanishvili N, Krylov V, Cuvelier C, et al. Digitized fluorescent RFLP analysis (fRFLP) as a universal method for comparing genomes of culturable dsDNA viruses: application to bacteriophages. Res Microbiol. 2007;158:572-81.
16. Kutter E, Sulakvelidze A. Bacteriophages: Biology and application. Boca Raton: CRC Press; 2005.
17. Matilla MA, Fang X, Salmond GP. Vulnalikeviruses are environmentally common agents of horizontal gene transfer in pathogens and biocontrol bacteria. ISME J. 2014;8:2143-7.
18. Petty NK, Foulds IJ, Pradel E, Ewbank JJ, Salmond GPC. A generalized transducing phage (φIF3) for the genomically sequenced Serratia marcescens strain Db11: a tool for functional genomics of an opportunistic human pathogen. Microbiol. 2006;152:1701-8.
19. Adams MH. Bacteriophages. New York: Interscience Publishers New York; 1959.
20. Appelmans R. Le dosage du bactériophage. Compt Rend Soc Biol. 1921;85:1098.
21. Parracho HMRT, Burrowes BH, Enright MC, McConville ML, Harper DR. The role of regulated clinical trials in the development of bacteriophage therapeutics. J Mol Genet Med. 2012;6:279-86.
22. Krylov V, Shaburova O, Krylov S, Pleteneva E. A genetic approach to the development of new therapeutic phages to fight Pseudomonas aeruginosa in wound infections. Viruses. 2013;5:15-53.
23. Edgar R, Friedman N, Molshanski-Mor S, Qimron U. Reversing bacterial resistance to antibiotics by phage-mediated delivery of dominant sensitive genes. Appl Environ Microbiol. 2012;78:744-51.
24. Chung IY, Sim N, Cho YH. Antibacterial efficacy of temperate phage-mediated inhibition of bacterial group motilities. Antimicrob Agents Chemother. 2012;56:5612-7.
25. Prudhomme M, Attaiech L, Sanchez G, Martin B, Claverys JP. Antibiotic stress induces genetic transformability in the human pathogen Streptococcus pneumoniae. Science. 2006;313:89-92.