Anderson, Neal G.Neal G. Anderson, Ph.D., has worked for over 20 years in chemical process R&D in the pharmaceutical industry. He earned a B.S. degree from the University of Illinois and a Ph.D. in medicinal chemistry from the University of Michigan and completed post-doctoral studies at McNeil Laboratories. With almost 18 years in process R&D at Bristol-Myers Squibb Co. in New Brunswick, New Jersey, Dr. Anderson has extensive hands-on experience in the laboratory, pilot plant, and manufacturing facilities. He has made key contributions to processes for the manufacture of four major drug substances, including captopril, and has participated in 12 manufacturing start-ups and successfully introduced many processes to pilot plants. He received the Bristol-Myers Squibb President's Award and spot awards, and his final position was Principal Scientist.In 1997, Dr. Anderson established Process Solutions L.L.C., a consulting firm offering 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.

1. Introduction to the role of process development 
2. Process safety
3. Route selection
4. Reagent selection
5. Solvent selection
6. Effects of water
7. In-process assays, in-process controls, and specifications
8. Practical considerations for scale-up
9. Optimizing processes by minimizing impurities
10. Optimizing organometallic reactions
11. Workup
12. Crystallization and purification
13. Final product form and impurities
14. Continuous operations
15. Refining the process for simplicity and ruggedness
16. Process validation and implementation
17. Troubleshooting
Glossary and indices: general, reagents, reactions, and drug substances

Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes 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."

Second Edition highlights: . Reflects the current thinking in chemical process R&D for small molecules . Retains similar structure and orientation to the first edition. . Contains approx. 85% new material . Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up) . Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes) . Replaces the first edition, although the first edition contains useful older examples that readers may refer to

• 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
• Presents guidelines for implementing and troubleshooting processes