The role of chemical engineering in pharmaceutical chemical process development.
The task of chemical process development in the pharmaceutical industry has grown into a multidisciplinary endeavor requiring years to complete. Increased competition in the pharmaceutical Additionally, the ever-tightening regulatory environment further compromises the business objective (ultimately, profits). This has required careful analysis of the activities within development. This work discusses the results of this analysis, which shows how a balance between minimal resource utilization and phased development achievements can be reached. The cycle of development, from inception to completion, is examined. Special emphasis is placed upon the role of chemical engineering and its appropriate deployment. Simple examples of the synergies that are possible between chemistry and chemical engineering are also given.
Landau
R N
RN
Novartis Pharmaceuticals Corporation, Technical Research & Development, East Hanover, NJ 07936, USA. ralph.landau@pharma.novartis.com
Blacklock
T J
TJ
Girgis
M J
MJ
Tedesco
A
A