- Modern spectroscopy based process analyzers such as NIR, Raman, 2D-fluorescence and other relevant sensor technologies as well as non invasive physical-chemical sensors for e.g. oxygen, pH and cell activity monitoring in cell culture disposable bioreactors.
- Multivariate data analysis tools, process monitoring and process control tools including data management tools.
An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation or to an entire manufacturing process and its quality assurance. The industry is slowly heading towards this QbD strategy, but substantial methodology and knowledge is lacking for all the mentioned tools, and in particular for the integration of all these components.
The Innovation Consortium is based on two main scientific tracks – split into three different major research topics. The scientific and professional level arrives from the partners well established research with these two main tracks: Sensor Technology and Data Analysis.
The following thematic innovation and research topics form the basis for the QbD project:
Sensor Technology
- To develop an on-line Raman spectrometer demonstrator with integrated fluorescence compensation in food & pharmaceutical processes.
- To develop a demonstrator of a robust handheld, potentially very inexpensive, sensor for measurement of one or more meat quality parameters such as color and fat content using state of the art optoelectronic components e.g. cutting edge LED technology.
- To optimize and adapt an on-line front face 2-D fluorescence demonstrator system to achieve a high sensitivity, reproducibility and robust monitoring in food & pharmaceutical processes with minimum demands for inter-instrument recalibration.
- To optimize opto-chemical sensor materials for e.g. pH and oxygen materials and integrate and adapt these in disposable bioreactors and polymer cell growth containers e.g. shaker flasks.
- To develop and optimize disposable polymer bioreactors to adapt non-invasive sensor technology.
- To develop and implement in-situ process microscopy for cell and crystal morphology characterization in chemical and fermentation processes.
- To follow and evaluate other relevant sensor and test technologies.
Data analysis
- To develop chemometric methods that can model multiple blocks of data and make such models operational for process engineers and process development groups.
- To develop general applicable advanced multivariate process control systems.
- To develop new and robust algorithms for complex multi-way data and to integrate models that make data analysis, pre-processing and modeling accessible to non-experts such as analytical chemists and process operators.
- To test data integration software with respect to raw data storage, chemometric model development, and exchange between multiple data sources (instruments and process datasets) and end users.
The different research topics are linked through the industrial applications all sensor and data analytical developments are performed on real industrial data originating from the industrial project applications. The applications cover food & pharmaceutical fermentation and recovery, disposable bioreactors in pharmaceutical production, processes in food & pharmaceutical and meat & dairy quality.
QbD is consisting of four vertical work packages (WP1-4) representing the food & pharmaceutical applications and five horizontal work packages (WP5-9) that covers fundamental research and technological development. Also included are two work packages (WP10-11) that complete the project by facilitating network, dissemination and training tasks, as well as project management to the list of activities.
