Practical Process Research and Development
A guide for Organic Chemists
Neal G. Anderson
- 488 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
Practical Process Research and Development
A guide for Organic Chemists
Neal G. Anderson
About This Book
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
Frequently asked questions
Information
Introduction
I. Introduction
Value | Factor |
$1,300,000,000 | Cost to bring a drug to market (1) |
5–20% of drug product price | CoG of API |
30% of the CoG for drug product | Cost of QC (2) |
Millions of dollars | Cost of failed drug formulation (3) |
As high as market will bear | Price of drug product to consumer (higher for US than for most countries) (4) |
$75,000 | The value of one additional year of life, set in 2005 by health economists (5) |
$200,000–$300,000 | Annual cost of US chemist or engineer for an employer |
About 95% | Portion of drug candidates that fail in pre-clinical or clinical studies |
About 30% | Portion of approved drugs that recoup development costs (6) |
8 years | Average time of development (goal is 5 years) |
20 years | Period for exclusive sales of a patented drug (US) |
20 – Development time | Years to recoup investment costs |
$1,000,000 | Sales lost for every day that a filing is delayed, if drug sales are $400 MM/year |