This book provides a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries. Process R&D describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. More people are being hired for work in this area as increasing numbers of drug candidates are identified through combinatorial chemistry and high-throughput screening. The book is directed to industrial (primarily organic) chemists, and academicians (particularly those involved in a growing number of start-up companies) and students who need insight into industrial process R&D. Current books do not describe hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." "Practical Process Research and Development" will be a valuable resource for researchers, managers, and graduate students.
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Neal G. Anderson is a synthetic organic chemist with over 40 years of experience in chemical process R&D in the pharmaceutical industry. He earned a B.S. degree in biology from the University of Illinois and a Ph.D. in medicinal chemistry from the University of Michigan, followed by industrial post-doctoral studies at McNeil Laboratories. He has extensive hands-on experience in the laboratory, pilot plant, and in manufacturing facilities. At Squibb / Bristol-Myers Squibb he made key contributions to processes for the manufacture of four major drug substances, including captopril, and has participated in 12 manufacturing start-ups and introductions of many processes to pilot plants. He received a BMS President's Award and spot awards, and his final position was Principal Scientist. In 1997, Anderson established Anderson’s Process Solutions L.L.C., a consulting firm based in the USA to offer practical guidance on developing and implementing processes for bulk pharmaceuticals and fine chemicals. As part of these consulting services, he presents courses on selected aspects of practical process R&D. He is experienced in laboratory research, scale-up, and technology transfer to ensure reproducibility and optimal product quality.
Bringing a compound to market quickly and profitably requires efficient and
cost-effective processes for preparing large amounts of the target compound
and intermediates. The key to rapid and successful process development is avoiding scale-up problems. However, an understanding of scale-up issues is rarely
taught in academia and may take years of industrial experience to acquire.
Practical Process Research & Development teaches how to anticipate and
avoid these problems when processes are being scaled up from the research lab or
pilot plant. The approach is pragmatic, with a minimum of theory and over
100 practical scale-up tips. Many tables and detailed reaction schemes
allow the reader to identify critical processing steps quickly. This
practical guide is essential reading for chemists and chemical engineers
involved in industrial process research and/or process development and for
anyone seeking a clearer understanding of how and why process R&D is conducted in the pharmaceutical and fine chemicals industries.
KEY FEATURES
· Provides insights into generating rugged, practical, cost-effective
processes for the chemical preparation of "small molecules"
· Breaks down process optimization into route, reagent, and solvent
selection, development of reaction conditions, workup, crystallizations, and more
· Describes how to anticipate and avoid difficulties in scaling up reactions
· Discusses guidelines for the timely development of processes
· Illuminates principles with examples from the recent literature
· Includes over 100 tips for rapid process development
· Presents guidelines for implementing and troubleshooting processes
· Written by an author with over 22 years experience in process R&D in
the pharmaceutical industry
"... A must reference on every process chemists (both the novice and the experienced practitioner) desk. This will be required reading by all new chemists, engineers and analysts in my department."
--Sean T. Nugent, Searle Research & Development
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