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Innovative multidisciplinary approach to pharma generic production (PHARMAGEN)
Start date: May 1, 2009, End date: Apr 30, 2011 PROJECT  FINISHED 

"The motivation of PHARMAGEN stems from a recognition that bulk Active Pharmaceutical Ingredients (API) manufacturers need to employ new synthesis routes and better manufacturing techniques for the manufacture of generics drugs. It is also recognised that a key enabling technology for achieving this goal entails greater use of continuous processes. A successful outcome will deliver processes which are more energy efficient, have higher yields, better controllability and quality, greater flexibility of output and faster development time. Most importantly, development of effective continuous processing methods will give European manufacturers a significant competitive advantage over Asian producers who have been progressively eroding the European know how and market share leadership in the API market. The PHARMAGEN project aims to improve the competitiveness of the participants by developing continuous production routes for three specific APIs selected by the SMEs. Batch pharmaceutical processes and continuous petrochemicals source their raw materials from the same basic chemical pool. Despite this, yield indexes (= wt reactants/wt final product, representing the effectiveness of the processes) for high throughput plants are typically in the region of 1,2 - 1,5, compared to more 10, for pharmaceutical batch processes. Thus, traditional pharmaceutical processes are characterised by waste levels of 90% plus. The PHARMAGEN project will allow participating SMEs to develop new and better chemical synthesis methods based on continuous processing. Further innovative modelling and process control will be developed. This will give European pharmaceuctical manufacturers a competitive advantage. Continuous processes can allow very high control level respect discontinuous ones, and this aspect is of paramount value for quality assurance in the manufacture of products for the human consumption."

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