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1Academic Journal
Συγγραφείς: D. S. Davydov, R. L. Parfenyuk, Z. V. Durmanova, R. E. Kazakov, A. A. Movsesyants, Д. С. Давыдов, Р. Л. Парфенюк, З. В. Дурманова, Р. Е. Казаков, А. А. Мовсесянц
Συνεισφορές: This study was conducted by the Scientific Centre for Expert Evaluation of Medicinal Products as part of the applied research funded under State Assignment No. 056-00026-24-01 (R&D Registry No. 124022200103-5), Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00026-24-01 на проведение прикладных научных исследований (номер государственного учета НИР № 124022200103-5)
Πηγή: Biological Products. Prevention, Diagnosis, Treatment; Том 24, № 3 (2024); 322-334 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 24, № 3 (2024); 322-334 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2024-24-3
Θεματικοί όροι: Quality by Design, bacteriophage preparations, phage therapy, personalised bacteriophage preparations, production of bacteriophage preparations, medicinal product lifecycle, marketing authorisation of medicines, multidrug resistance, лекарственные препараты бактериофагов, фаготерапия, персонализированные препараты бактериофагов, производство препаратов бактериофагов, обращение лекарственных средств, государственная регистрация лекарственных средств, множественная лекарственная устойчивость
Περιγραφή αρχείου: application/pdf
Relation: https://www.biopreparations.ru/jour/article/view/602/917; https://www.biopreparations.ru/jour/article/downloadSuppFile/602/1040; Cooper CJ, Khan Mirzaei M, Nilsson AS. Adapting drug approval pathways for bacteriophage-based therapeutics. Front Microbiol. 2016;7:1209. https://doi.org/10.3389/fmicb.2016.01209; Pirnay JP, Ferry T, Resch G. Recent progress toward the implementation of phage therapy in Western medicine. FEMS Microbiol Rev. 2022;46(1):fuab040 https://doi.org/10.1093/femsre/fuab040; Hall AR, Vos DD, Friman V-P, Pirnay J-P, 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(16):5646–52. https://doi.org/10.1128/aem.00757-12; Schooley RT, Biswas B, Gill JJ, Hernandez-Morales A, Lancaster J, Lessor L. Development and use of personalized bacteriophage-based therapeutic cocktails to treat a patient with a disseminated resistant Acinetobacter baumannii infection. Antimicrob Agents Chemother. 2017;61(10):e00954–17. https://doi.org/10.1128/AAC.00954-17; Verbeken G, Pirnay JP, Lavigne R, Jennes S, De Vos D, Casteels M, Huys I. Call for a dedicated European legal framework for bacteriophage therapy. Arch Immunol Ther Exp. 2014;62(2):117–29. https://doi.org/10.1007/s00005-014-0269-y; Pirnay JP, Verbeken G, Rose T, Jennes S, Zizi M, Huys I, et al. Introducing yesterday’s phage therapy in today’s medicine. Future Virol. 2012;7(4):379–90. https://doi.org/10.2217/fvl.12.24; Van Nieuwenhuyse B, Van der Linden D, Chatzis O, Lood C, Wagemans J, Lavigne R, et al. Bacteriophage-antibiotic combination therapy against extensively drug-resistant Pseudomonas aeruginosa infection to allow liver transplantation in a toddler. Nat Commun. 2022;13(1):5725. https://doi.org/10.1038/s41467-022-33294-w; Gill JJ, Hyman P. Phage choice, isolation, and preparation for phage therapy. Curr Pharm Biotechnol. 2010;11(1):2–14. https://doi.org/10.2174/138920110790725311; Glonti T, Pirnay JP. In vitro techniques and measurements of phage characteristics that are important for phage therapy success. Viruses. 2022;14(7):1490. https://doi.org/10.3390/v14071490; Carlton RM. Phage therapy: past history and future prospects. Arch Immunol Ther Exp. 1999;47(5):267–74. PMID: 10604231; Egido JE, Costa AR, Aparicio-Maldonado C, Haas PJ, Brouns SJJ. Mechanisms and clinical importance of bacteriophage resistance. FEMS Microbiol Rev. 2022;46(1):fuab048. https://doi.org/10.1093/femsre/fuab048; Pirnay JP, De Vos D, Verbeken G, Merabishvili M, Chanishvili N, Vaniichoutte M, et al. The phage therapy paradigm: preˆt-a`-porter or sur-mesure? Pharm Res. 2011;28(4):934–7. https://doi.org/10.1007/s11095-010-0313-5; Mattey M, Spencer J. Bacteriophage therapy — cooked goose or phoenix rising? Curr Opin Biotechnol. 2008;19(6):608–12. https://doi.org/10.1016/j.copbio.2008.09.001; Wouters OJ, McKee M, Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009–2018. JAMA. 2020;323(9):844–53. https://doi.org/10.1001/jama.2020.1166; Jault P, Leclerc T, Jennes S, Pirnay JP, Que Y-A, Resch G, et al. Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial. Lancet Infect Dis. 2019;19(1):35–45. https://doi.org/10.1016/S1473-3099(18)30482-1; Servick K. Drug development. Beleaguered phage therapy trial presses on. Science. 2016;352(6293):1506. https://doi.org/10.1126/science.352.6293.1506; Merabishvili M, De Vos D, Verbeken G, Kropinski AM, Vandenheuvel D, Lavigne R, et al. Selection and characterization of a candidate therapeutic that lyses the Escherichia coli O104:H4 strain from the 2011 outbreak in Germany. PLoS One. 2012;7(12):e52709. https://doi.org/10.1371/journal.pone.0052709; Henein A. What are the limitations on the wider thera peutic use of phage? Bacteriophage. 2013;3(2):e24872. https://doi.org/10.4161/bact.24872; Verbeken G, Pirnay JP, De Vos D, Jennes S, Zizi M, Lavigne R, et al. Optimizing the European regulatory frame-work for sustainable bacteriophage therapy in human medicine. Arch Immunol Ther Exp (Warsz). 2012;60(3):161–72. https://doi.org/10.1007/s00005-012-0175-0; Fauconnier A. Regulating phage therapy: the biolog ical master file concept could help to overcome regulatory challenge of personalized medicines. EMBO Rep. 2017;18(2):198–200. https://doi.org/10.15252/embr.201643250; Shapiro SZ. The HIV/AIDS vaccine researchers’ orientation to the process of preparing a US FDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting. Vaccine. 2002;20(9–10):1261–80. https://doi.org/10.1016/s0264-410x(01)00453-4; Aslam S, Yung G, Dan J, Reed S, LeFebvre M, Logan C, et al. Bacteriophage treatment in a lung transplant recipient. J Heart Lung Transplant. 2018;37(4):S155–6. https://doi.org/10.1016/j.healun.2018.01.376; Chan BK, Turner PE, Kim S, Mojibian HR, Elefteriades JA, Narayan D. Phage treatment of an aortic graft infected with Pseudomonas aeruginosa. Evol Med Public Health. 2018;(1):60–6. https://doi.org/10.1093/emph/eoy005; Furr CLL, Lehman SM, Morales SP, Rosas FX, Gaidamaka A, Bilinsky IP, et al. P084 bacteriophage treatment of multidrug-resistant Pseudomonas aeruginosa pneumonia in a cystic fibrosis patient. J Cyst Fibros. 2018;17:S83. https://doi.org/10.1016/S1569-1993(18)30381-3; LaVergne S, Hamilton T, Biswas B, Kumaraswamy M, Schooley RT, Wooten D. Phage therapy for a multidrugresistant Acinetobacter baumannii craniectomy site infection. Open Forum Infect Dis. 2018;5(4):ofy064. https://doi.org/10.1093/ofid/ofy064; Greene J, Goldberg RB. Isolation and preliminary characterization of lytic and lysogenic phages with wide host range within the streptomycetes. J Gen Microbiol. 1985;131(9):2459–65. https://doi.org/10.1099/00221287-131-9-2459; Harshey RK. Phage Mu. In: Calendar R, ed. The bacteriophages. Boston: Springer; 1988.; Yarmolinsky MB, Sternberg N. Bacteriophage P. In: Calen dar R, ed. The bacteriophages. Boston: Springer;1988.; Jensen EC, Schrader HS, Rieland B, Thompson TL, Lee KW, Nickerson KW, Kokjohn TA. Prevalence of broad-host-range lytic bacteriophages of Sphaerotilus natans, Escherichia coli, and Pseudomonas aeruginosa. Appl Environ Microbiol. 1998;64(2):575–80. https://doi.org/10.1128/AEM.64.2.575-580.1998; Pantucek R, Rosypalova A, Doskar J, Kailerova J, Ruzicko va V, Borecka P, et al. The polyvalent staphylococcal phage phi 812: its host-range mutants and related phages. Virology. 1998;246(2):241–52. https://doi.org/10.1006/viro.1998.9203; Khan MA, Satoh H, Katayama H, Kurisu F, Mino T. Bacteriophages isolated from activated sludge processes and their polyvalency. Water Res. 2002;36(13):3364–70. https://doi.org/10.1016/s0043-1354(02)00029-5; Sullivan MB, Waterbury JB, Chisholm SW. Cyanophages infecting the oceanic cyanobacterium Prochlorococcus. Nature. 2003;424(6952):1047–51. https://doi.org/10.1038/nature01929; O’Flaherty S, Ross RP, Meaney W, Fitzgerald GF, Elbreki MF, Coffey A. Potential of the polyvalent anti-Staphylococcus bacteriophage K for control of antibiotic-resistant staphylococci from hospitals. Appl Environ Microbiol. 2005;71(4):1836–42. https://doi.org/10.1128/AEM.71.4.1836-1842.2005; El-Arabi TF, Griffiths MW, She YM, Villegas A, Lingohr EJ, Kropinski AM. Genome sequence and analysis of a broadhost range lytic bacteriophage that infects the Bacillus cereus group. Virol J. 2013;10:48. https://doi.org/10.1186/1743-422X-10-48; Mirzaei KM, Nilsson AS. Isolation of phages for phage therapy: a comparison of spot tests and efficiency of plating analyses for determination of host range and efficacy. PLoS One. 2015;10(3):e0118557. https://doi.org/10.1371/journal.pone.0118557; DeWyngaert MA, Hinkle DC. Bacterial mutants affecting phage T7 DNA replication produce RNA polymerase resistant to inhibition by the T7 gene 2 protein. J Biol Chem. 1979;254(22):11247–53. PMID: 387768; Qimron U, Marintcheva B, Tabor S, Richardson CC. Genomewide screens for Escherichia coli genes affecting growth of T7 bacteriophage. Proc Natl Acad Sci USA. 2006;103(50):19039–44. https://doi.org/10.1073/pnas.0609428103; James TD, Cashel M, Hinton DM. A mutation within the beta subunit of Escherichia coli RNA polymerase impairs transcription from bacteriophage T4 middle promoters. J Bacteriol. 2010;192(21):5580–7. https://doi.org/10.1128/JB.00338-10; Azam AH, Hoshiga F, Takeuchi I, Miyanaga K, Tanji Y. Analysis of phage resistance in Staphylococcus aureus SA003 reveals different binding mechanisms for the closely related Twortlike phages SA012 and SA039. Appl Microbiol Biotechnol. 2018;102(20):8963–77. https://doi.org/10.1007/s00253-018-9269-x; Merril CR, Biswas B, Carlton R, Jensen NC, Creed GJ, Zullo S, Adhya S. Long-circulating bacteriophage as antibacterial agents. Proc Natl Acad Sci USA. 1996;93(8):3188–92. https://doi.org/10.1073/pnas.93.8.3188; Sander M, Schmieger H. Method for host-independent detection of generalized transducing bacteriophages in natural habitats. Appl Environ Microbiol. 2001;67(4):1490–3. https://doi.org/10.1128/AEM.67.4.1490-1493.2001; Beumer A, Robinson JB. A broad-host-range, generalized transducing phage (SN-T) acquires 16S rRNA genes from different genera of bacteria. Appl Environ Microbiol. 2005;71(12):8301–4. https://doi.org/10.1128/AEM.71.12.8301-8304.2005; DelCasale A, Flanagan PV, Larkin MJ, Allen CC, Kulakov LA. Analysis of transduction in wastewater bacterial populations by targeting the phage-derived 16S rRNA gene sequences. FEMS Microbiol Ecol. 2011;76(1):100–8. https://doi.org/10.1111/j.1574-6941.2010.01034.x; Yen M, Camilli A. Mechanisms of the evolutionary arms race between Vibrio cholerae and Vibriophage clinical isolates. Int Microbiol. 2017;20(3):116–20. https://doi.org/10.2436/20.1501.01.292; Chan BK, Sistrom M, Wertz JE, Kortright KE, Narayan D, Turner PE. Phage selection restores antibiotic sensitivity in MDR Pseudomonas aeruginosa. Sci Rep. 2016;6:26717. https://doi.org/10.1038/srep26717; Henry M, Biswas B, Vincent L, Mokashi V, Schuch R, Bishop-Lilly KA, Sozhamannan S. Development of a high throughput assay for indirectly measuring phage growth using the OmniLog(TM) system. Bacteriophage. 2012;2(3):159–67. https://doi.org/10.4161/bact.21440; Estrella LA, Quinones J, Henry M, Hannah RM, Pope RK, Hamilton T, et al. Characterization of novel Staphylococcus aureus lytic phage and defining their combinatorial virulence using the OmniLog(R) system. Bacteriophage. 2016;6(3):e1219440. https://doi.org/10.1080/21597081.2016.1219440; Давыдов ДС, Парфенюк РЛ, Дурманова ЗВ, Меркулов ВА, Мовсесянц АА. Особенности государственной регистрации и обеспечения качества лекарственных препаратов бактериофагов в Российской Федерации. БИОпрепараты. Профилактика, диагностика, лечение. 2023;23(2):181–93. https://doi.org/10.30895/2221-996X-2023-431; https://www.biopreparations.ru/jour/article/view/602