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: April 12, 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”