The business case for continuous manufacturing of pharmaceuticals

Manufacturing in the pharmaceutical industry is presently characterized as a batch production system, which has existed in its current form for decades. This structure is the result of historical regulatory policy as well as the conservative nature of the industry. Recent clarification by US and European regulatory bodies has opened the possibility to new approaches to the manufacturing process. This combined with changes in the market for the pharmaceutical industry has accelerated the rate at which new manufacturing technologies are explored. Continuous manufacturing is a paradigm shift in the pharmaceutical industry manufacturing structure, encompassing several new technologies and systems. The business impact of continuous manufacturing has not been well defined. This assessment aims to compare a continuous manufacturing process to a batch manufacturing process for a particular Novartis product. The product has an established batch production process. Cost estimates and the continuous process cost is estimated using a four-step process: defining the process flow, performing the material balance, estimating the capital costs, and estimating the operating costs. This analysis shows that for the particular Novartis product considered, a continuous process is an improvement over the batch process in four performance characteristics: capital investment, operating cost, throughput time, and working capital requirement. Thesis Supervisor: Bernhardt Trout Title: Professor of Chemical Engineering Thesis Supervisor: Ernst Berndt Title: Louis E. Seley Professor in Applied Economics This page has been intentionally left blank Acknowledgements I would like to acknowledge several individuals who were invaluable in completing this project. I would first like to thank Walter Bisson for sponsoring the project and for his support and mentorship during the project. Additionally, I would like to thank several people at Novartis who contributed to multiple aspects of the project. These people include Marc Achermann, Pat Brennan, Roland Messer, Berthold Schenkel, and Hedinn Valthorsson. I would not have been able to complete my work without your expertise and support. I would also like to thank Sussane Mai and Luanne Shock introducing me to so many great people at Novartis and making me comfortable in Basel. I would also like to thank my MIT supervisors, Ernst Berndt and Bernhardt Trout. You both provided excellent support and advice during the internship and thesis writing. Finally, I would like to dedicate this thesis to my lovely wife Michelle, for her support and patience throughout my two years as an MIT student. You are always there to listen to me and give me advice when I am challenged by the day to day requirements of class work, internship, and thesis writing. Thank you for being such a wonderful wife who makes my life