2012|13 Annual Report Fraunhofer IGB

PHARMACY 73 Priv.-Doz. Dr. Steffen Rupp The current challenges faced by the pharmaceutical industry include the accurate diagnosis of diseases and their personalized therapy, the development of new active agents and the en- hancement of the effectiveness of new drugs through improved formulations. The pharmacy business area at the Fraunhofer IGB is involved in developing solutions for drug screening, pharmaceutical biotechnology, pharmaceutical chemistry and drug release and formulation. We identify new drugs by means of the targeted use of cell-based assays, for instance for im- munomodulatory substances or anti-infectives. Structure-activity correlations are performed on active hits. Potential active compounds are characterized in vitro by using complex organotypic 3D primary cell models (skin, intestine, lungs, liver) for effectiveness, absorption, distribution in the organ model, metabolization and toxicity. These investigations – corresponding to phase I clinical studies – are complemented by molecular methods such as gene expression and pro- teome analysis as well as by histology and confocal Raman spectroscopy. The aim is to identify toxic side-effects of potential active agents and their metabolites at an early, pre-clinical stage. In the ﬁeld of pharmaceutical biotechnology we are developing processes to manufacture pharmaceutical proteins. These extend from the development of expression vectors and strain development in microorganisms and mammalian cells to the optimization of fermentation pro- cesses and the puriﬁcation of the pharmaceuticals – including by means of molecularly imprint- ed nanoparticles (NanoMIPs). Cooperation within the Fraunhofer network enables us to supply customers with proteins produced in compliance with GMP (good manufacturing practice) for clinical testing. For the formulation of active agents we develop nanoparticle-based structures which deliver drugs directly to the target location and then release them in a controlled man- ner. In addition, we develop cell-based therapeutics and produce samples for clinical trials accord- ing to GMP guidelines. Our quality control systems identify potential contaminants (microor- ganisms, viruses) in a non-destructive way using spectroscopic, cell-based or molecular meth- ods according to the guidelines of GLP (good laboratory practice) or GMP. Our work in the pharmacy business area is enriched in many ways by the collaboration of dif- ferent departments at the Fraunhofer IGB. We also contribute to the activities of the Fraun- hofer Group for Life Sciences, which cover the development of medicines from screening for active agents to the production of test samples for clinical trials.

2012|13 Annual Report Fraunhofer IGB

Pages