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Guidelines for Bacteriophage Product Certification

  • Alan Fauconnier
Protocol
Part of the Methods in Molecular Biology book series (MIMB, volume 1693)

Abstract

Following decades in the wilderness, bacteriophage therapy is now appearing as a credible antimicrobial strategy. However, this reemerging therapy does not rekindle without raising sensitive regulatory concerns. Indeed, whereas the European regulatory framework has been basically implemented to tackle ready-to-use pharmaceuticals produced on a large scale, bacteriophage therapy relies on a dynamic approach requiring a regulation on personalized medicine, nonexistent at present. Because of this, no guideline are currently available for addressing the scientific and regulatory issues specifically related to phage therapy medicinal products (PTMP).

Pending to the implementation of an appropriate regulatory framework and to the development of ensuing guidelines, several avenues which might lead to PTMP regulatory compliance are explored here. Insights might come from the multi-strain dossier approach set up for particular animal vaccines, from the homologous group concept developed for the allergen products or from the licensing process for veterinary autogenous vaccines. Depending on national legislations, customized preparations prescribed as magistral formulas or to be used on a named-patient basis are possible regulatory approaches to be considered. However, these schemes are not optimal and should thus be regarded as transitional.

Key words

Phage therapy medicinal product Magistral formula Named-patient Autogenous vaccine Homologous group Multi-strain dossier Regulatory framework Personalized medicine 

Notes

Acknowledgements

The author would like to thank Sofie Termont and Daniel De Vos for critical reading of the manuscript and valuable editorial comments. Conflict of interests: The author declares no competing financial interests. Although the author works for regulatory authorities, the views expressed in this chapter are his personal opinion. As such, they may not be understood, interpreted, or quoted as being made on behalf of, or reflecting the position of, any agency or institution.

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Copyright information

© Springer Science+Business Media LLC 2018

Authors and Affiliations

  1. 1.Federal Agency for Medicines and Health ProductsBrusselsBelgium
  2. 2.Culture in vivo ASBLNivellesBelgium

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