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2015|16 Annual Report Fraunhofer IGB - PHARMACY

75 PHARMACY Current challenges faced by the pharmaceutical industry include improving personalized therapy, the development of new active agents, and the enhancement of the effectiveness of drugs through improved formulations. In the pharmacy business area, Fraunhofer IGB develops solutions for target and drug screening, pharmaceutical biotechnology and chemistry, includ- ing for the formulation and targeted delivery and release of drugs. Screening and validation of drugs – Based on its own patents Fraunhofer IGB has devel- oped various array technologies, high-throughput sequencing methods and human tissue models and is therefore able to elucidate host-pathogen interactions and make available targets for new anti-infectives. By targeted use of cell-based assays, we identify new drugs, e.g. for immunomodulatory substances or anti-infectives, on the basis of structure-activity correlations. Using complex organotypic 3D complex tissue models – both “healthy” and “diseased” tissues – we characterize potential active compounds in vitro. In particular, models of the human barriere tissues, i.e. skin, intestine, respiratory tract and the blood-brain barrier, are constructed as tissue models from primary or iPS cells, to investigate the absorption, dis- tribution in organ models, toxicity and effectiveness of new drugs. In these tissue models we simulate clinical regimens to identify new prognostic markers, mechanisms of resistance and effectiveness by molecular methods such as gene expression and proteome analysis as well as by histology and confocal Raman spectroscopy. Manufacturing and processing – We develop processes for the production of pharmaceuti- cal proteins ranging from the establishment of new expression vectors, the strain development in microorganisms and mammalian cells, and the optimization of fermentation processes to the purification of the pharmaceuticals e offer the production of clinical IMPs in compliance with GMP (Good Manufacturing Practice) regulations via internal Fraunhofer cooperation. Increasingly, we are also implementing cell-free biotechnological methods, which allow for the fast optimization of pharmaceutical proteins, produced in milligram amounts, that can be characteri ed while using the cell-based systems ikewise, other highly efficient cell-free applications are the introduction of non-canonical amino acids or the coupling of drug and targeting molecules. Formulation – With regard to the formulation of active agents, we are developing nanopar- ticulate structures that deliver drugs directly to the target location and then release them in a controlled manner. Virus-like particles represent a novel approach for the packaging and intravenous targeting of drugs. With our expertise, we contribute to the offerings of the Fraunhofer Group for Life Sciences, facilitating a scope of activity covering the development of medicines from the screening for active agents to the production of test samples.