The pharmaceutical biotechnology department at Franhofer-ITEM (Prof. Dr. Holger Ziehr) is manufacturing the components of an inhalative preparation from the phages selected by the DSMZ in accordance with the specifications of the GMP quality assurance system. The necessary process development on production scale is now well advanced. The aim is to create a manufacturing platform that allows new phages to be produced in pharmaceutical quality by adapting only a few parameters.
To date, the selected phages have been produced at Fraunhofer ITEM in the planned scale and quality of pharmaceutical active ingredients. The feasibility of the platform approach is becoming increasingly apparent. The focus of the work is now increasingly on questions of galenic development (i.e. the type of preparation) and thus on the stability and shelf life of the phage both as an active ingredient and as a test drug.