Genetic engineering and genomics are playing a vital role in many drugs synthesis industries so biotechnological engineers are much interested in these techniques.

In addition as the guidance is produced by the ICH and filters down through the member regulatory
systems into law, and in non ICH member states who perceive it as a gold standard, tough standards become
very hard for small local manufactures to meet.
The book written by experienced professionals gives an overview of how to apply biotechnology in drug development process.