Bacteriophage Production in Compliance with Regulatory Requirements

Pirnay, Jean‐Paul; Merabishvili, Maia; Raemdonck, Hilde Van; Vos, Daniël De; Verbeken, Gilbert

doi:10.1007/978-1-4939-7395-8_18

Cited by 42 publications

(34 citation statements)

References 34 publications

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“…Although phage research started over 100 years ago and their therapeutic applications have been studied from the beginning [ 45 ], necessary safety requirements for phage preparations are still being discussed [ 2 , 46 ]. Different phage preparations are currently available on the market or under specific experimental treatment programs in Georgia, Poland, Russia, Slovakia and several clinical trials related to phage therapy have been started in the Western World.…”

Section: Discussionmentioning

confidence: 99%

Rapid Identification of Intact Staphylococcal Bacteriophages Using Matrix-Assisted Laser Desorption Ionization-Time-of-Flight Mass Spectrometry

Štveráková

Šedo

Benešík

et al. 2018

Viruses

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Staphylococcus aureus is a major causative agent of infections associated with hospital environments, where antibiotic-resistant strains have emerged as a significant threat. Phage therapy could offer a safe and effective alternative to antibiotics. Phage preparations should comply with quality and safety requirements; therefore, it is important to develop efficient production control technologies. This study was conducted to develop and evaluate a rapid and reliable method for identifying staphylococcal bacteriophages, based on detecting their specific proteins using matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) profiling that is among the suggested methods for meeting the regulations of pharmaceutical authorities. Five different phage purification techniques were tested in combination with two MALDI-TOF MS matrices. Phages, either purified by CsCl density gradient centrifugation or as resuspended phage pellets, yielded mass spectra with the highest information value if ferulic acid was used as the MALDI matrix. Phage tail and capsid proteins yielded the strongest signals whereas the culture conditions had no effect on mass spectral quality. Thirty-seven phages from Myoviridae, Siphoviridae or Podoviridae families were analysed, including 23 siphophages belonging to the International Typing Set for human strains of S. aureus, as well as phages in preparations produced by Microgen, Bohemia Pharmaceuticals and MB Pharma. The data obtained demonstrate that MALDI-TOF MS can be used to effectively distinguish between Staphylococcus-specific bacteriophages.

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Section: Discussionmentioning

confidence: 99%

Rapid Identification of Intact Staphylococcal Bacteriophages Using Matrix-Assisted Laser Desorption Ionization-Time-of-Flight Mass Spectrometry

Štveráková

Šedo

Benešík

et al. 2018

Viruses

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“…Ils sont brièvement résumés dans le tableau 1. Pour être utilisé en thérapeutique, un bactériophage devra être défini et « labellisé » en répondant à un cahier des charges précis tel que proposé par certains auteurs [76,77]. Comme nous l'avons vu, l'utilisation de la phagothérapie en santé humaine ou dans l'agroalimentaire (animale ou végétale) doit suivre des règles strictes afin de garantir toutes les conditions…”

Section: Conclusion Et Perspectivesunclassified

Antibacterial applications of bacteriophages

Ansaldi¹,

Boulanger²,

Brives³

et al. 2018

Virologie

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Dès 1917, dans l'article où il décrit ses premières observations et propose le nom de bactériophage, Félix d'Hérelle rapporte une première utilisation de ces virus pour traiter des infections bactériennes, donnant ainsi naissance à la phagothérapie. Le développement de cette application a montré qu'il était possible de mettre en place des traitements ciblant spécifiquement les bactéries, tels que ceux basés sur l'utilisation d'antibiotiques. Ces derniers, de par leur très grande efficacité et simplicité d'utilisation, ont provoqué le quasi-abandon de la phagothérapie. Aujourd'hui, un nombre croissant de bactéries pathogènes pour l'homme présente des phénotypes de résistance à plusieurs familles d'antibiotiques. Les infections causées par ces bactéries imposent l'utilisation de molécules au spectre d'activité toujours plus large et placent certains patients en situation d'impasse thérapeutique. Cet état de fait a relancé les recherches pour permettre le déploiement de la phagothérapie afin de traiter des patients mais aussi des animaux et des plantes. En fait, les domaines d'applications thérapeutiques des bactériophages s'élargissent au fur et à mesure que les agents antibactériens de nature chimique sont remis en cause, voire interdits. Cette revue revient sur les principes fondamentaux des applications thérapeutiques des bactériophages et expose les données récentes dans les domaines pour lesquels une exploitation commerciale est en cours ou sur le point d'émerger.

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“…The quality of a biological drug is harder to guarantee and control than that of a chemical. An adaptation of the regulation is necessary [9] which, in particular, will have to take into account the fact that such a drug can be a cocktail of several bacteriophages and probably to envisage its preparation within the framework of an individualized preparation [54] for a personalized medicine [8,55]. This personalized preparation may be sometimes necessary if the bacterial infection is unusual (opportunistic bacteria) and/or that no bacteriophages adapted have not yet been isolated (see Box 1) for a such bacteria.…”

Section: A) Productionmentioning

confidence: 99%

“…Today it is easy to detect and eliminate these residues. Active research has developed on this topic in recent years [9].…”

Section: B) Utilisationmentioning

confidence: 99%

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Indications and Limitations of Phage Therapy in Human Medicine: Personal Experience and Literature Review

Dublanchet¹,

Patey²,

Mazure³

et al. 2018

Preprint

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Bacteriophages, viruses that are widespread throughout the world, are highly specific for bacteria, usually of a single species and often of a particular strain. After being discovered and isolated 100 years ago, their use, called phage therapy, was instituted in medicine two years later and quickly used around the world to treat various bacterial infections. In the West, phage therapy was overshadowed in the second half of the 20th century by antibiotic therapy, which was then thought to be the definitive solution. But because of the increase in bacterial resistance to antibiotics, the idea of using bacteriophages in medicine has been reawakened. The innumerable observations reported over the years in the literature constitute an invaluable experience. We and some of our colleagues have, in the last decade treated some patients compassionately. With the available documentation and our own experience we discuss the potential indications and limitations of phage therapy. The observation of the increasing number of therapeutic failures in the announced perspective of a post-antibiotic era, we believe, that the introduction of bacteriophages into the therapeutic arsenal seems conceivable today to two preconditions: that their production as biologic drug meets current regulatory standards and that the benefit-risk assessment was conducted in a modern setting. Phage therapy could be applied as a substitution or supplement to antibiotic therapy under multiple circumstances in different modes, precise indications and limits.

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Bacteriophage Production in Compliance with Regulatory Requirements

Cited by 42 publications

References 34 publications

Rapid Identification of Intact Staphylococcal Bacteriophages Using Matrix-Assisted Laser Desorption Ionization-Time-of-Flight Mass Spectrometry

Rapid Identification of Intact Staphylococcal Bacteriophages Using Matrix-Assisted Laser Desorption Ionization-Time-of-Flight Mass Spectrometry

Antibacterial applications of bacteriophages

Indications and Limitations of Phage Therapy in Human Medicine: Personal Experience and Literature Review

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