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Introduction of the course
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Program July, 10-14 (2006)
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Mission of Bionovations.org: Stimulation of innovations in biopharmaceutical manufacturing sciences by the organization of multidisciplinary, state of art workshops, courses and practices. Crucial in our approach is the exchange of ideas and experience by people originating from Companies and Academia

Our view on Innovation in Biopharmaceutical Process Development and Manufacturing

So far the manufacture of biopharmaceuticals (= proteins and vaccines) is more an art than a science. Due to the introduction of novel technologies ( e.g -omics) and the far reaching possibilities of data management, on line monitoring and control, the art of cell cultivation technology is evolving towards science. There is therefore a need for innovative approaches in process development in order to bring the manufacturing of the next generation biopharmaceuticals to a next level, introducing manufacturing science. The manufacture of these products and the development of processes for new products need a multidisciplinary approach in which all disciplines involved from genetic engineering of both prokaryotic and eukaryotic cells to bioreactor engineering and down-stream processing of the proteins have to be incorporated.

Only recently, researchers in the field of cell cultivation technology are becoming aware that the far from optimal conditions in the bioreactor used for this process step have a clear influence on the characteristics of the recombinant proteins produced by the cells. Understanding the relation between process parameters and product characteristics in combination with adequate control of these process parameters will result in more potent biopharmaceuticals for life threatening diseases developed in a faster and more cost effective manner. The Process Analytical Technology (PAT) Guidance document issued 2004 by FDA needs to be an integral part of manufacturing science for biopharmaceuticals. The typical PAT-tools contribute to the incorporation of quality into these products.

Bionnovations.org task is to create awareness and use of innovative concepts for process development and process design by organizing workshops, summer courses, consultancy and supporting the development of PAT applications.

The Summer Course is supported by The Graduate School VLAG (Advanced Studies in Food Technology, Agrobiotechnology, Nutrition and Health Sciences) of Wageningen University (The Netherlands)