(238d) Model-Based Process Control in API Manufacturing: A QbD-Vantage! Conference: AIChE Annual MeetingYear: 2014Proceeding: 2014 AIChE Annual MeetingGroup: Pharmaceutical Discovery, Development and Manufacturing ForumSession: Application of Quality By Design in API Process Development Time: Tuesday, November 18, 2014 - 9:45am-10:10am Authors: Mukherjee, S., AbbVie Inc. Greenfield, M., AbbVie Inc. Quality-by-design (QbD) is a fundamental tenet of any process development group that is engaged in designing robust and efficient processes for commercial API manufacture. The quest for QbD in API synthesis culminates into extensive knowledge generation on various unit operations such as reactions, purifications, and isolations, in the form of fundamental mechanistic understanding, multi-parameter (multivariate) interactions and models. Models bring in predictive ability that is valuable in streamlining R&D work and to develop scientifically sound design space for process parameters. A model could also be applied as an element of process control that satisfies quality requirements or as a process monitoring/trending tool in manufacturing. Presented is a case-study developed for evaluation of model-based process control in API manufacturing.