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Quality and safety requirements for sustainable phage therapy products.
Pharm Res ; 32(7): 2173-9, 2015 Jul.
Article em En | MEDLINE | ID: mdl-25585954
The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In addition, phages have the capacity to rapidly overcome bacterial resistances, which will inevitably emerge. To maximally exploit these advantage phages have over conventional drugs such as antibiotics, it is important that sustainable phage products are not submitted to the conventional long medicinal product development and licensing pathway. There is a need for an adapted framework, including realistic production and quality and safety requirements, that allows a timely supplying of phage therapy products for 'personalized therapy' or for public health or medical emergencies. This paper enumerates all phage therapy product related quality and safety risks known to the authors, as well as the tests that can be performed to minimize these risks, only to the extent needed to protect the patients and to allow and advance responsible phage therapy and research.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Bacterianas / Bacteriófagos / Terapia Biológica / Farmacorresistência Bacteriana Múltipla Limite: Humans Idioma: En Revista: Pharm Res Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Bacterianas / Bacteriófagos / Terapia Biológica / Farmacorresistência Bacteriana Múltipla Limite: Humans Idioma: En Revista: Pharm Res Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos