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.