Multi-aspect safety assessment of bacteriophage products dedicated for animal health

During July 18th - 22nd our Research & Development team participated in the 6th Viruses of Microbes conference, which took place in Guimarães, Portugal. Our colleague Ewelina Wójcik presented the results of one of the recently conducted studies on Multi-aspect safety assessment of bacteriophage products dedicated for animal health.

Developing a modern phage commercial product requires selecting appropriate cocktail components and choosing the right product format that supports effective delivery of active phages to the targeted site. Proteon Pharmaceuticals created the innovative technology platform that allows to successfully develop phage-based products and implement new strategies allowing to control pathogenic bacteria which affect animal production industry. Proteon's platform allows to design highly effective products consisting of a mixture of carefully selected and genotypically characterized virulent phages that eliminate pathogenic bacteria, without causing side effects, while improving performance on the farm. 

Proteon’s flagship product BAFASAL® is a feed additive for industrial poultry sector protecting birds against Salmonella. The preparation was examined in line with the EFSA guidelines proving its high safety for human, birds, and environment. 

Moreover, multiple studies confirmed high effectiveness in reducing Salmonella in birds and in the environment of poultry production sites. 

While phages have an excellent safety profile, employing phage products on a large scale in the food production sector is perceived as a novel technological approach. Bacteriophages used in the industry can make their way into humans through food chain or exposure. A broad acceptance of the phage technology might require an additional effort to better understand potential effects of their introduction into food chain and work environment.

Proteon, together with MedBiome Inc., applied an in vitro assay called RapidAIM to investigate the effect of BAFASAL® on human gut microbiome. RapidAIM (rapid assay of an individual microbiome) measures compositional and functional changes in the gut microbiome in response to dietary and therapeutic interventions, therefore it can be used to estimate the impact of products on the microbiota. In this study, we investigated whether BAFASAL® phage introduction to the human microbiome affects its composition and function. We treated five individual adult-derived gut microbiomes with active and inactive mixtures of BAFASAL®. This study, the first of its kind, has important implications for how we measure food safety and maintain the safety of workers in the food-processing industry exposed to these preparations.

Multi-omics analyses, including 16S rRNA gene sequencing and metaproteomic, revealed that ex vivo human gut microbiota composition and function were unaffected by BAFASAL® treatment, providing an additional measure for its safety.