 |
 |
WebCAST seminar on "Challenges and Opportunities in the Continuous Manufacturing of Pharmaceuticals" by G. V. Rex Reklaitis and Zoltan K. Nagy Department of Chemical Engineering at Purdue University Date: April 17, 2013, 2-4 pm (EDT) Dial-in from the comfort of your office to hear the presentation. Deadline to Register: extended to April 15, 2013 (details at www.castdiv.org/WebCAST.htm) This is a joint CAST / CACHE initiative. The registration rate is: • free for the first 100 CAST members and CACHE departments (including industrial affiliates) • for all others, $25/connection. Joining the CAST Division of AIChE only costs $10/year.] Abstract: 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 market opportunities, 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 of attention in the industry and been the focus of research in the NSF Engineering 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 presentation will conclude with a brief overview of some additional manufacturing innovations targeting small scale manufacturing configurations suitable for delivery of individualized medicine. Biographical Sketch: G.V. Rex Reklaitis is Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering at Purdue University and currently deputy director of the ERC on Structured Organic Particulate Systems. At Purdue he has served as the Head of the School of Chemical Engineering and Director of the Computer Integrated Process Operations Center. 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. Current research interests include applications of process systems methodology to improve pharmaceutical product design, development, manufacture and administration as well as systems studies of integrated energy networks. He was educated at the Illinois Institute of Technology (BS ChE), received MS and PhD degrees from Stanford University, has held an NSF Postdoctoral fellowship (Zurich, Switzerland) and Senior Fulbright Lectureship (Vilnius, Lithuania). He is a member of the US National Academy of Engineering, fellow of AIChE, and past Editor-in-Chief of Computers & Chemical Engineering. He has received the Computing in Chemical Engineering Award (AICHE), the ChE Lectureship Award (ASEE), the George Lappin and Van Antwerpen Awards (AIChE) and the Long Term Achievements in Computer Aided Process Engineering Award of the European Federation of Chemical Engineering and the Illinois Institute of Technology Professional Achievement Award. He has served on the Board of Directors of AICHE, the Council for Chemical Research and the CACHE Corporation. He has published over 240 papers and book chapters and edited/authored eight books. Dr. Nagy is a Professor of Chemical Engineering at Purdue University and also holds a European Research Council Research Adjunct Professorship at Loughborough 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 design and robust control of batch and continuous crystallization systems and integrated particulate manufacturing processes for pharmaceutical applications. He has more than 200 publications in these areas, and has given numerous invited talks at conferences, universities and companies worldwide. Dr. Nagy is the Founding Editor of the Pharmaceutical Engineering Subject area of Chemical Engineering Research and Design, and associate editor for several other journals in the area of process control. Dr Nagy is member of the steering committee of the American Association for Crystallization Technologies, and the Crystallization Working Party of the European Federation of Chemical Engineers. He received major awards and best paper prizes from IEEE, IFAC, European Federation of Chemical Engineering, Institute of Chemical Engineering, Council of Chemical Research, Royal Academy of Engineering and the European Research Council. Save the date! May 7, 2-4 pm (EDT), WebCAST seminar by Prof. Christodoulos Floudas, “Multi-scale Approaches for Optimizing Novel Hybrid Feedstock Energy Processes”