Bacteriophages: new therapies with “old” anti-infective agents
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.