Therapie-Phagen: Voraussetzung für die Anwendung geschaffen

Wittmann, Johannes; Bunk, Boyke; Korf, Imke H. E.; Wienecke, Sarah; Spröer, Cathrin

doi:10.1007/s12268-023-1917-8

Cited by 1 publication

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“…This is because the culture of phages in a phage bank and the amplification of phages are not activities that a community pharmacy or a doctor’s practice can manage in addition to all their other activities. Rather, it is expected that dedicated phage banks will be established—as can be observed to some extent today [ 3 , 93 , 99 ]—that can provide the collection and characterisation of therapeutically required phages. Either these phage banks or associated facilities can then amplify the phages in the quantity and quality required for treatment on demand.…”

Section: Application Settings Of Phage Therapymentioning

confidence: 99%

The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation

Faltus

2024

Viruses

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Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, the article shows how the planned legislative revisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 may affect the legal future of phage therapy.

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Section: Application Settings Of Phage Therapymentioning

confidence: 99%

The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation

Faltus

2024

Viruses

View full text Add to dashboard Cite

show abstract

Therapie-Phagen: Voraussetzung für die Anwendung geschaffen

Cited by 1 publication

References 2 publications

The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation

The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation

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