Completion of phage production, preparation of the clinical trial

Using the phages selected by the DSMZ, the Fraunhofer-ITEM’s Pharmaceutical Biotechnology Unit is developing manufacturing processes for the phages that, as active pharmaceutical ingredients, will be the active ingredients of a drug to be administered by inhalation. The aim is to achieve a largely generic phage production technology that will later allow adaptation to the production of newly added phages by adjusting only a small number of parameters.

In the meantime, the Phage4Cure phages have been produced in the required quantities as active ingredients and delivered to the project partners for preclinical studies on pharmacology and toxicology issues. For the first clinical application study scheduled in 2022, the same phages were produced once again as active ingredients and additionally as phage test drugs, but this time in pharmaceutical quality under the specifications of the quality assurance system GMP (“Good Manufacturing Practice”).

At the moment, the project focus is on the evaluation and documentation of the preclinical studies as well as the preparation of the extensive documentation for the application for the clinical trial – this is being done in close coordination between Charité, Charité Research Organisation GmbH and the regulatory authorities. The first clinical application study is expected to start in late summer 2022.

Completion of work at ITEM, start of preclinical testing

The department of Pharmaceutical Biotechnology at Fraunhofer-ITEM (Prof. Dr. Holger Ziehr) develops production processes for active phage ingredients from the phages which have been selected by DSMZ, which will be the active components (active ingredients) of the drug to be administered by inhalation. The aim is to develop a generic phage manufacturing platform that allows the production of new phages in pharmaceutical quality by adjusting only a few parameters. This process is now nearly completed.
In the meantime, selected phages have been produced in the intended scale and quality as active pharmaceutical ingredients, subsequently filled in vials under sterile conditions and handed over to the project partners ITEM in Hannover and Charité in Berlin, where preclinical studies on pharmacological and toxicological issues have already started.
Work at ITEM is increasingly focusing on questions of galenic development (i.e. the composition of the dosage form) and the associated stability and durability of the phages in the test drug. The production of the investigational drug to be used in the clinical study is scheduled for 2021.

Progress report of Fraunhofer ITEM

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.