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ePaper created 2014-05-07, 13:23:14 | version 1.30.01
PHARMACY 83 Priv.-Doz. Dr. Steffen Rupp The current challenges faced by the pharmaceutical industry include improving personalized therapy, the development of new active agents, and enhancing the effectiveness of drugs through improved formulations. The Pharmacy business area at the Fraunhofer IGB works on developing solutions for drug screening, on questions in the fields of pharmaceutical biotech- nology and chemistry, as well as on drug formulation and targeted release. We identify new drugs e.g. for immunomodulatory substances or anti-infectives by means of the targeted use of cell-based assays and structure-activity correlations. Using complex or- ganotypic 3D primary cell models (skin, intestine, lungs), potential active compounds are char- acterized in vitro for effectiveness, absorption, distribution in organ models and toxicity. These investigations – corresponding to phase I clinical studies – are complemented by molecular methods such as gene expression and proteome analysis, as well as by histology and confo- cal Raman spectroscopy. The aim is to identify toxic side effects of potential active agents and their metabolites at a pre-clinical stage. In the field of pharmaceutical biotechnology we work on developing processes to manufacture pharmaceutical proteins. These range from the development of expression vectors and strain development in microorganisms and mammalian cells to the optimization of fermentation processes and the purification of the pharmaceuticals. Cooperation within the Fraunhofer net- work enables us to supply customers with proteins produced in compliance with GMP (Good Manufacturing Practice) for clinical testing. With regard to the formulation of active agents, we are developing nanoparticle-based structures that deliver drugs directly to the target location and then release them in a controlled manner. We are increasingly also making use of cell-free biotechnological methods, which allow fast optimization of pharmaceutical proteins, produc- tion of milligram amounts and characterization using the cell-based systems cited above. Other highly efficient “cell-free” applications are the introduction of non-canonical amino acids and the coupling of drug and targeting molecules. In addition, our activities include developing cell-based therapeutics and the production of GMP-compliant sample amounts. Our quality control systems identify potential contaminants (microorganisms, viruses) by non-destructive means, using spectroscopic, cell-based or molecu- lar methods based on GLP (Good Laboratory Practice) and GMP guidelines. We contribute our expertise to the Fraunhofer Group for Life Sciences, facilitating a scope of activity covering the development of medicines from screening for active agents to the produc- tion of test samples.