Challenges and Opportunities in the Continuous Manufacturing of Pharmaceuticals Originally delivered Apr 17, 2013 Developed by: CAST - Computing & Systems Technology Division Type: Archived WebinarLevel: Intermediate Duration: 2 hours PDHs: 0.00 Share This Post: Preview Webinar: The pharmaceutical industry is a large, high value added manufacturing sector, with annual worldwide sales of nearly $1 trillion. The traditional manufacturing mode in this sector has been batch operation. However, recent advances in technologies, changes in the regulatory climate and continuously drivers for cost reduction have provided a unique opportunity for the introduction of advanced manufacturing technologies. Continuous processing is considered to be one of the key technologies that can provide significant innovation in the pharmaceutical sector also motivated by the vision of developing “on demand” personalised medicines. In addition to offering better product consistency, and overall process efficiency, continuous manufacturing has the potential to provide more distributed and even mobile manufacturing systems that could be located at the point of use, improving access to novel medicines, opening new marketopportunities, reducing costs, driving innovation and speeding time to market. However, to be able to exploit the advantages of continuous manufacturing processes in an industry characterised by high value, high variety and low volume products obtained through a network of distributed manufacturing systems, advances are required in fundamental process understanding, continuous processing and equipment in particular for chemical solids and in measurement, modeling and control methodologies.The presentation will provide an overview of the advantages and challenges, including regulatory aspects, related to the continuous manufacturing of pharmaceuticals, from synthesis to formulation of the final product. We will provide a brief overview of aspects related to continuous production of active pharmaceutical ingredients (API) and then focus on methodologies for the continuous processing of slurries and solids, which present key challenges in enabling the overall continuous manufacturing process. Crystallization is the key unit operation that connects the primary (API synthesis) and secondary (design of delivery form) manufacturing processes.The solid properties such as shape and crystal size distribution (CSD) of the API obtained at the crystallization step will strongly influence the efficiency of the secondary manufacturing process. Modeling and control approaches for continuous crystallization will be presented that allow better control of the product CSD.Continuous secondary manufacturing of the final product from the API isolated at the crystallization step has also received quite a bit ofattention in the industry and been the focus of research in the NSFEngineering Research Center for Structured Organic Particulate Systems, a multi-university collaboration with industry. The focus here again is on innovative use of on-line measurement, process modelling and control, exceptional events management and real time process management. Process configurations including the full range of unit operations from powder feeding to tablet coating are under active consideration. The rudiments of process flowsheet modelling for such operations are beginning to be assembled offering the potential for design optimization. The presentationwill conclude with a brief overview of some additional manufacturinginnovations targeting small scale manufacturing configurations suitable for delivery of individualized medicine. Presenter(s): Zoltan Nagy Dr. Nagy is a Professor of Chemical Engineering at Purdue University and also holds a European Research Council Research Adjunct Professorship atLoughborough University, UK, where he was a professor of process systems engineering and Director of the Departmental Pharmaceutical Engineering Research Centre, before joining Purdue in Fall 2012. Dr Nagy has over 12 years of experience in advanced process control, process analytical technologies and crystallization modeling and control approaches. His current research focuses on the application of systems approaches and tools in the...Read more G.V. Rex Reklaitis Gintaras.V. (Rex) Reklaitis is Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering at Purdue University. He has served as Head of the School of Chemical Engineering and deputy director of the NSF Engineering Research Center on Structured Organic Particulate Systems. His expertise lies in process systems engineering, the application of information and computing technologies to process and product design, process operations and supply chain management.Read more Checkout Checkout Do you already own this? Log In for instructions on accessing this content. Pricing AIChE Member Credits 0.5 AIChE Members $69.00 AIChE Undergraduate Student Members Free AIChE Graduate Student Members Free Non-Members $99.00 Webinar content is available with the kind permission of the author(s) solely for the purpose of furthering AIChE’s mission to educate, inform and improve the practice of professional chemical engineering. All other uses are forbidden without the express consent of the author(s).