PhageFire project was finalized in March 2024 with all tasks accomplished. In second period the consortium had already tested in field a first formulation and in the last period, results from the in-field tests performed in the second campaign have been analyzed. In addition, our knowledge of the phages has been enlarged; therefore, the final phages cocktail has changed to make PhageFire product even more aggressive against E. Amylova.
Once final selection of phages to be in the cocktail was agreed propagation methodologies to multiply the different components of the cocktail and production parameters were determined to have the most efficient production set-up.
Final aim of the consortium is to launch PhageFire into the market due to its potential benefits for pome fruit growers and the sector. However, previous to commercialization the consortium needs to confirm PhageFire environmental and human safety. in that sense, the consortium has performed all necessary studies required by the European regulation in matter of PPP and a dossier to apply for the emergency use authorization in different MS has been prepared and is now under evaluation. Selection of the MS was based on market and sales strategy. Finally In order to protect the consortium´s interests a patent has been submitted to EPO.
At the beginning of the project some problems due to cross-contamination during the isolation of phages were faced. These problems resulted in an innovative isolation process, and new phages identified and characterized. Final cocktail includes phages that were compatible with each other during co-infection and that exhibited different receptor specificities and maximal efficacy in vitro.
The first field trials allowed to identify problems with the adjuvants when preparing in-situ the final version of the cocktail to apply in field. This made necessary to re-evaluate the adjuvants, final formulation includes UV-protective agents and surfactants environmental friendly agents.
To perform the in-field trials, it was necessary to get official permits from EU. During the season 2023, permissions were obtained to perform studies in ES, HG, PT, BE, GR and RO
The dossier to get the emergency authorization includes efficacy studies (field trials), environmental and safety risks studies and physical chemical studies. The results of all studies are official since they have been performed under GLP guidelines and are satisfactory in general. All tests confirm efficacy against E. Amylova and safety of the project.
The latest changes on the formulation of the product have affected the work done of the industrial partner since they have to re-define the propagation parameters of the new phages included in the cocktail after first round of field trials in 2022. Things like the temperature, propagation strains, their OD or the MOI need to be adjusted again. Also, adjustments in the culture medium have been applied to improve the stability of the product. During this period the titer of the cocktail regarding the PFU/ml of the phages has improved reaching a peak of 1x10^11PFU/ml in some experience. The product will contain 1x10^11PFU/ml.
All this knowledge needs to be protected. During this period consortium has discussed the best way to protect the results of the project. Different options like trade secret or register trademark were studied but the most suitable option for all partners was a patent application. Finally, an application to the EPO has been submitted. This patent application is extendable to any MS for a period of time of one year. Important work has been also done on the marketing and commercialization plan. A communication campaign aimed at generating new leads and raising awareness of the product was successfully launched during March 2024.
