Quality by Design has been of increasing importance for both the Food and the Pharmaceutical industries for some years, but the technological development is far behind the philosophy and concepts formulated. The industries have been hesitant despite a pull from regulatory bodies to implement the concepts to enable them to utilize the Process Analytical Technologies relevant to achieve Quality by Design. Only few very early adaptors have had some initial experience with Process Analytical Technologies and the major part of industry and the supporting instrumentation sector are sitting on the fence. The QbD seeks to contribute to the progress and actively take a lead on this development to:
- Enable the processing industries to test and demonstrate novel sensor technologies and data analysis methods and get documented experience with QbD solutions.
- Demonstrate the market potential and accelerate the development of new sensor systems and associated data integration in the instrumentation and process consultancy industries.
The project was initiated on November 1st 2008, and will continue until 31st January 2012. The funding from Forsknings- og Innovationsstyrelsen is DKK 18.7 million corresponding to a 100% funding of the costs of the research partner (KU-LIFE) and 75 % of the costs of the technological service partner (DELTA). The participating companies finance their own costs of participating, corresponding to DKK 26.5 million or 54% of the total budget which amounts to 49.4 MKr. All participants aim at a committed participation giving the project a size of 40.4 Person-years of effort.
