Practical Process Research and Development

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.

Foreword by K. Barry Sharpless. Foreword by Jerome L. Moniot. Preface. About the Author. Approaches to Process Development. Route Selection. Reagent Selection. Solvent Selection. Running the Reaction. Effects of Water. In-Process Controls. Optimizing the Reaction by Minimizing Impurities. Optimizing Catalytic Reactions. Work-Up. Tools for Purifying the Product: Column Chromatography, Crystallization, and Reslurrying. Final Product Form and Impurity Considerations. Vessels and Mixing. Preparing for and Implementing the Scale-up Run. Troubleshooting. Chiral Syntheses. General Index. Reaction Type Index. Reagent Index.