Smart specialization process in Slovenia has opened space for further enhancement of collaboration between further industry and research organization, which has been very active with past research programs – based on this research and new services, which can be developed in collaboration with pharmaceutics industry, we plan to cover the open pace on global market, which we plan to deliver in the field of simulating very expensive biological drug production.

Pharmaceutical and IT industry are both one of the strongest economic businesses worldwide and the current prognosis is that their growth will still continue in the future. The perspective is even more promising when both industry branches collaborate on common programs. Recently, Novartis announced that its eye care division Alcon has entered into an agreement with a division of Google Inc. to in-license its "smart lens" technology for all ocular medical uses.

Since pharmaceuticals industry and IT industry are both one of the most important economic drivers in Slovenia, there are also great opportunities for further sustained growth by combining both fields to be prepared for future health challenges. Especially in biopharmacy, where the produced drugs are complex biological active ingredients, the development and production costs are extremely high. Sandoz Biopharmaceuticals Mengeš, which is one of six biopharmaceuticals centers at Novartis, is a production and development site for biosimilars, a generic version of biological drugs. Despite high biosimilar development costs (US$ 800 million) and long development time (8 years), the field of biosimilars is worth to invest. Berlin Institute IGES1 estimates that health care systems in only eight EU countries can save up US$ 33 billion till 2020 by introducing biosimilars to the EU market.

The goal of the proposed project is to shorten development time and to improve robustness of the production process for biosimilars by introducing the latest IT technologies such as high performance computing (HPC). HPC technology is a key factor for success of the project. Biopharmaceuticals are derived by cell cultures, meaning that production process understating depends on big data analysis enabling insight into cellular processes.

The state-of-the-art IT technology will be used for the project implementation including cluster and cloud computing, big-data analytics and graph theoretical approaches. By introducing bioinformatics models of complex bioprocess and by introducing a new system for on-line controlling and monitoring of production there will be generated a new knowledge that will result in faster scale-ups, improved success rate of process transfers and in more robust production.

The proposed project will contribute directly into two priority areas of SPS: “Health”, and “Smart usage of resources”. In the »Health« priority, important contributions are expected in the development of biomedical substances and their production technologies supported by extensive computer simulation and experimental validation. In the priority »Smart usage of resources« new tools for process development and process momnitoring will be developed with advanced IT tools, which will substantially reduce the consumption of energy, human effort, number of experiments and other resources.

However developed tools and principles will have also wider applicability for other industries like chemical, environmental and food industries and will enable novel opportunities in IT sector as well.

However developed tools and principles will have also wider applicability for other industries like chemical, environmental and food industries, which are by the order of magnitude larger than pharmaceuticals, and will thus enable many novel opportunities in IT sector as well.