Moira Monika Schuler

An industrial process leading to the production of biologicals consists of a series of batch processes, involving various process parameters to be monitored. A single production generates several thousands of data points, stored in various forms. Regulatory agencies, (ex. FDA) compel record and storage of all data, even though in most companies the acquired data is neither transformed into information, nor into knowledge. Since 2004, regulatory agencies are urging the pharmaceutical companies to apply knowledge management tools in order to learn from historical data, to gather deeper process understanding and to ensure a holistic approach to produce high-quality products. However, implementation of such approaches is scare. There is an urgent need for tools that allow combining expert knowledge, historical data and multivariate analysis to provide meaningful data as a basis for reliable production processes.