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Quality-Controlled Small-Scale Production of a Well-Defined Bacteriophage Cocktail for Use in Human Clinical Trials
Open accessAbstract
We describe the small-scale, laboratory-based, production and quality control of a cocktail, consisting of exclusively lytic bacteriophages, designed for the treatment of Pseudomonas aeruginosa and Staphylococcus aureus infections in burn wound patients. Based on successive selection rounds three bacteriophages were retained from an initial pool of 82 P. aeruginosa and 8 S. aureus bacteriophages, specific for prevalent P. aeruginosa and S. aureus strains in the Burn Centre of the Queen Astrid Military Hospital in Brussels, Belgium. This cocktail, consisting of P. aeruginosa phages 14/1 (Myoviridae) and PNM (Podoviridae) and S. aureus phage ISP (Myoviridae) was produced and purified of endotoxin. Quality control included Stability (shelf life), determination of pyrogenicity, sterility and cytotoxicity, confirmation of the absence of temperate bacteriophages and transmission electron microscopy-based confirmation of the presence of the expected virion morphologic particles as well as of their specific interaction with the target bacteria. Bacteriophage genome and proteome analysis confirmed the lytic nature of the bacteriophages, the absence of toxin-coding genes and showed that the selected phages 14/1, PNM and ISP are close relatives of respectively F8, phiKMV and phage G1. The bacteriophage cocktail is currently being evaluated in a pilot clinical study cleared by a leading Medical Ethical Committee.
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Cited by
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Singer, M., Bulled, N., Ostrach, B., & Mendenhall, E. (2017) · The Lancet · doi:10.1016/s0140-6736(17)30003-x · Cited by 1,491
Pros and cons of phage therapy
Loc-Carrillo, C., & Abedon, S. T. (2011) · Bacteriophage · doi:10.4161/bact.1.2.14590 · Cited by 1,020
Formulation, stabilisation and encapsulation of bacteriophage for phage therapy
Malik, D. J., Sokolov, I. J., Vinner, G. K., Mancuso, F., Cinquerrui, S., Vladisavljevic, G. T., Clokie, M. R. J., Garton, N. J., Stapley, A. G. F., & Kirpichnikova, A. (2017) · Advances in Colloid and Interface Science · doi:10.1016/j.cis.2017.05.014 · Cited by 594
Bacteriophage Therapy: Discovery, Development, and FDA Approval Pathways
Niazi, S. K. (2025) · Pharmaceuticals · doi:10.3390/ph18081115 · Cited by 56
Bacteriophage–host interaction: from splendid isolation into a messy reality
Brüssow, H. (2013) · Current Opinion in Microbiology · doi:10.1016/j.mib.2013.04.007 · Cited by 49
Metadata
- Authors
- Merabishvili, M., Pirnay, J.-P., Verbeken, G., Chanishvili, N., Tediashvili, M., Lashkhi, N., Glonti, T., Krylov, V., Mast, J., Van Parys, L., Lavigne, R., Volckaert, G., Mattheus, W., Verween, G., De Corte, P., Rose, T., Jennes, S., Zizi, M., De Vos, D., & Vaneechoutte, M.
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2009-03-20
- Volume
- 4
- Issue
- 3
- Pages
- e4944
- ISSN
- 1932-6203 (ISSN-L)
- OpenAlex
- W2070373460
- Cited by
- 511
- References
- 0
- FWCI
- 21.12
- Type
- journal article
- Language
- en
- Open access
- gold
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- The paper
- Merabishvili, M., Pirnay, J.-P., Verbeken, G., Chanishvili, N., Tediashvili, M., Lashkhi, N., Glonti, T., Krylov, V., Mast, J., Van Parys, L., Lavigne, R., Volckaert, G., Mattheus, W., Verween, G., De Corte, P., Rose, T., Jennes, S., Zizi, M., De Vos, D., & Vaneechoutte, M. (2009). Quality-Controlled Small-Scale Production of a Well-Defined Bacteriophage Cocktail for Use in Human Clinical Trials. PLoS ONE. https://doi.org/10.1371/journal.pone.0004944
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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