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.

1. Introduction to the role of process development 2. Process safety3. Route selection 4. Reagent selection5. Solvent selection6. Effects of water7. In-process assays, in-process controls, and specifications8. Practical considerations for scale-up9. Optimizing processes by minimizing impurities10. Optimizing organometallic reactions 11. Workup12. Crystallization and purification13. Final product form and impurities14. Continuous operations 15. Refining the process for simplicity and ruggedness16. Process validation and implementation17. TroubleshootingGlossary and indices: general, reagents, reactions, and drug substances