(267f) Continuous Processing: Application to Process Design and Material Supply
AIChE Annual Meeting
2015
2015 AIChE Annual Meeting Proceedings
Pharmaceutical Discovery, Development and Manufacturing Forum
Applications of Continuous Processing in the Manufacture of Pharmaceuticals: Drug Substance I
Tuesday, November 10, 2015 - 10:35am to 11:00am
Continuous processing represents a powerful methodology that can be applied both to process design and material supply from reactions to isolations. Within process design, augmenting typical approaches with continuous operation enhances the mapping of the design space. Specific points within the design space, represented by each steady state, can be probed and characterized generating deeper understanding and allowing for the extraction of kinetic information not otherwise readily accessible. Continuous operation also increases the options with regard to material supply offering advantages with regard to impurity profile, control of solid state attributes such as PSD and form, capacity and safety. However, given that continuous processing is still within its infancy with regard to adaption by the pharma industry, there are significant technical and regulatory challenges to be overcome to successfully supply material. A number of case studies applying continuous processing to process design and material supply will be presented.