New Directions in Bioprocess Modeling and Control: Maximizing Process Analytical Technology Benefits

Description

Models offer benefits even before they are put on line. Based on years of experience, the authors reveal in New Directions in Bioprocess Modeling and Control that significant improvements can result from the process knowledge and insight that are gained when building experimental and first-principle models for process monitoring and control. Doing modeling in the process development and early commercialization phases is advantageous because it increases process efficiency and provides ongoing opportunities for improving process control. This technology is important for maximizing benefits from analyzers and control tool investments. If you are a process design, quality control, information systems, or automation engineer in the biopharmaceutical, brewing, or bio-fuel industry, this handy resource will help you define, develop, and apply a virtual plant, model predictive control, first-principle models, neural networks, and multivariate statistical process control. The synergistic knowledge discovery on bench top or pilot plant scale can be ported to industrial scale processes. This learning process is consistent with the intent in the Process Analyzer and Process Control Tools sections of the FDA s Guidance for Industry PAT A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. It states in the Process Analyzer section of the FDA s guidance: For certain applications, sensor-based measurements can provide a useful process signature that may be related to the underlying process steps or transformations. Based on the level of process understanding these signatures may also be useful for the process monitoring, control, and end point determination when these patterns or signatures relate to product and process quality.