The looming antimicrobial resistance crisis has spurred fresh interest in using naturally occurring bacterial viruses (bacteriophages) to treat bacterial infections, a process termed phage therapy (PT). Although they are generally regarded as safe, phages pose a problem for regulatory bodies as they don’t fit the classical approval pathway for medicinal products. Since 2018, as the first country in Europe, Belgium has implemented a magistral framework in which a consortium of Sciensano labs evaluates the quality of phage products. However, some key knowledge gaps remain, and need to be addressed to achieve sustainable implementation of PT.
The SAPHETY project will implement state-of-the-art technology in this quality control process, investing in both genomic and immunologic assays to advance knowledge on genetic stability and bacterial contamination of phage productions. The focus will be on the analysis of the genetic stability of phage productions, the presence of contaminating (mobile) genetic elements and other bacterial remnants (endo- and exotoxins, peptidoglycan, etc.) which could cause adverse reactions. This data will help to define EU-wide minimal quality levels for personalized phage products at the level of the European Pharmacopeia commission, which will start discussions on a General Chapter on bacteriophages in 2021.
