Building process knowledge using inline spectroscopy, reaction calorimetry and reaction modeling--the integrated approach.
For over two decades, reaction engineering tools and techniques such as reaction calorimetry, inline spectroscopy and, to a more limited extent, reaction modeling, have been employed within the pharmaceutical industry to ensure safe and robust scale-up of organic reactions. Although each of these techniques has had a significant impact on the landscape of process development, an effective integrated approach is now being realized that combines calorimetry and spectroscopy with predictive modeling tools. This paper reviews some recent advances in the use of these reaction engineering tools in process development within the pharmaceutical industry and discusses their potential impact on the effective application of the integrated approach.
Tummala
Srinivas
S
Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08903, USA. srinivas.tummala@bms.com
Shabaker
John W
JW
Leung
Simon S W
SS
D002151:Calorimetry; D008956:Models, Chemical; D009930:Organic Chemicals / Q000138:chemical synthesis / Q000737:chemistry*; D013057:Spectrum Analysis; D018511:Systems Integration; D013678:Technology, Pharmaceutical / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
D009930:Organic Chemicals