Pharmaceutical processes include, among others, chemical synthesis, formulation of solid oral dosage forms, and manufacture of biological molecules via cell culture, fermentation or synthesis. Synthetic processes for small molecules have common elements with the fine chemicals industry.  Processes for solid dose oral formulations revolve around the science and technology of organic solids processing, which has commonality with other industries such as catalyst manufacture, munitions, food, detergents, etc.  The processes for biomolecules share many elements with biofuels and biofeedstocks.  However, the regulatory framework for pharmaceuticals is much more complex than other industries, and as a result the state of the art is different than in other industries.

This talk addresses opportunities to enhance the development of these pharmaceutical processes and the impact of properly engineered development on the resulting manufacturing processes.  This is crucial for the industry in this age of distributed supply chains and outsourcing, which is also present in other industries.  Ensuring the supply and quality of pharmaceutical products requires a renewed emphasis on acquiring fundamental understanding during development so that the process can be controlled effectively in this array of suppliers.  Furthermore the time and cost of development must be reduced.  The thousands of manufacturers involved in pharmaceuticals around the globe cannot reach this level of engineering on their own.  The talk presents examples of current and potential academic contributions, such as dynamic analysis for process control, the science of particulate systems and the development of continuous manufacturing for solid oral dosage forms, and perspectives for the use of continuous approaches in developing biomanufactured products. 

Speaker

Mauricio Futran is Professor and Chair of Chemical and Biochemical Engineering at Rutgers University.  He came to this position after 28 years of pharmaceutical product and process development work at Merck and Co. and Bristol-Myers Squibb, where he was Vice President of Process R&D.  His areas of expertise include all aspects of process development, technology transfer, validation, regulatory compliance, new product registration worldwide, external manufacturing and partnership development.  He is a recognized leader in applying automation physical property prediction and modeling to process development.

Professor Futran is a member of the National Academy of Engineering, the past chair of its Chemical Engineering section, and has served on its peer committee, the Board of Chemical Sciences and Technology, and an NRC panel.  As an AIChE member he serves on the awards committee.  He is was a member (and chair for 9 years) of the Princeton Chemical and Biological Engineering external board, and has been a member of the external boards for the University of Illinois at Urbana Champaign, Georgia Tech, and Rutgers.