Phage4Cure project

The aim of the project Phage4Cure in Braunschweig is to establish bacteriophages (phages for short) as anti-infective drugs against bacterial infections with Pseudomonas aeruginosa – a bacterium that has been associated with hospital-acquired infections and cystic fibrosis. Using phages previously selected by Leibniz Institute DSMZ, the Braunschweig-based Fraunhofer ITEM Division of Pharmaceutical Biotechnology is developing manufacturing processes to supply these phages as active pharmaceutical ingredients of a future drug for inhaled administration. The manufacturing process includes cultivation of the production strain, phage replication in the production strain and harvesting, purification by chromatography, formulation, and fill and finish of the investigational medicinal product. The aim is to develop a largely standardized, platform-like production technology that will later allow the manufacturing process to be adapted to other phages by adjusting only a few parameters.

The scientists managed to produce the specific phages in the required quantities and pharmaceutical quality as active ingredients and to deliver them to the project partners at Charité Berlin and Fraunhofer ITEM in Hannover for preclinical pharmacology and toxicology studies. Pharmaceutical-grade phage-based investigational medicinal products have been manufactured for phase-I clinical trials in compliance with the GMP quality assurance system. The first clinical trial with bacteriophages in Germany is expected to start in the second half of 2022.