Continuous Lyophilization of Pharmaceutical Products in Unit Doses
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About the Webinar
The new paradigm of pharmaceutical industry is to move from batch to continuous processes so as to satisfy the stringent requirements of quality, safety and efficiency set by regulatory authorities and reduce production costs. In this perspective, freeze-drying needs to be completely rethought, making it more integrated in the chain of production of drugs and more flexible to respond to variations in market needs. The future of freeze-drying, as a downstream process, is therefore to move from batch to continuous.
Over the past decades many ideas regarding continuous freeze-drying has been proposed, but none of them has been successfully applied. The objective of this work is to demonstrate the feasibility of an innovative concept to produce lyophilized unit-dose drugs using a continuous process. This novel strategy was demonstrated to improve both yield and vial-to-vial uniformity, giving all those advantages that are typical of continuous technology such as flexibility and elimination of process scale-up from laboratory to industrial scale.
About Our Speakers: Robert Pisano and Bernhardt L. Trout
Roberto Pisano is a Professor of Chemical Engineering at Politecnico di Torino (Italy), where he received his Ph.D. in 2009. Professor Pisano’s research focuses on the application of both computational and experimental methods to the development and design of chemical processes with complex dynamics, with particular emphasis to pharmaceutical processing and formulation of both small molecules and biologics to be lyophilized. He has published 60 papers and currently has 4 patents issued or pending.
Bernhardt L. Trout is the Raymond F. Baddour, ScD, (1949) Professor of Chemical Engineering and Director of the Novartis-MIT Center for Continuous Manufacturing. He received his S.B. and S.M. degrees from MIT and his Ph.D. from the University of California at Berkeley. In addition, he performed post-doctoral research at the Max-Planck Institute. Trout’s research focuses on molecular engineering, specifically the development and application of both computational and experimental molecular-based methods to engineering pharmaceutical formulations and processes with unprecedented specificity. Since 1999, he has focused on molecular engineering for biopharmaceutical formulation, primarily liquid formulation, but also lyophilized formulation. A major aspect of his research focuses on developing both microscopic and macroscopic models to design stable formulations efficiently. In 2007, with several colleagues from MIT, he set up the Novartis-MIT Center for Continuous Manufacturing, a $85 million partnership with the objective of transforming pharmaceutical manufacturing. In addition to Novartis, he has worked with many other pharmaceutical companies in research or consulting. He has published over 190 papers and has 22 patents issued or pending.
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