An Ontology-Based Information Management System for Pharmaceutical Product Development

The development of pharmaceutical products and processes involves laboratory scale, pilot plant scale and commercial scale manufacturing. Through these steps, data on synthesis routes, material properties, processing steps, and scale up parameters are collected and used. Recent advances in process analytical technologies resulted in a large volume of heterogeneous data, which requires a systematic model of the associated information for optimal use. In addition, software tools are used to support decision-making and process modeling during process development. However, each tool creates and uses information in a specific form, making connection difficult amongst the tools and allowing little interaction with experimental data. In this work, an integrated information management system based on structured information is presented. This system is built to explicitly specify important concepts like physical properties and experiments using ontologies. Based on the developed ontologies, an information access and repository system is developed to allow convenient access to the repository for both the user and software tool. The infrastructure, designed to be accessible from the web, would allow simple search and browse as well as complicated queries, which can only be efficiently answered through the use of semantics in the information. This structure is extended to consider integration with software tools through the definition of an applicationagnostic medium. Such an integrated information infrastructure provides a systematic approach to managing, sharing and reusing information, and is expected to result in considerable reduction in pharmaceutical process development time and better quality assurance.