Pharmaceutical Process Development
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.
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.
Tuesday, September 11, 2012
Registration 6:00 PM
Dinner 6:30 PM
Program 7:30 PM
Rutgers University, Busch Campus Dining Room A
non-Rutgers attendees: please park in Lot 67B and “event parking” sign will mark the lot
Rutgers students should follow the normal parking regulations
608 Bartholomew Road
Piscataway, NJ 08854
Members and Guests …………………..……$35
Unemployed/Retired Section members …$15
Please Pre-Register to get an accurate count for dinner.
Call Andy Soos at (908) 604-2670 or e-mail at firstname.lastname@example.org by Friday Sept 7,2012
This meeting has been partially sponsored.
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Have you heard someone speak that would be of interest to our group? Would you like to speak? We’re interested in both technical and general interest presentations. Let us know.
Executive Committee Meeting
The Executive Committee meeting for September will be held on Sept 18 at Paisano’s Pizza at 6:30 pm. All members are welcome.