Chapter 2: Process Research and Development in the Pharmaceutical Industry: Origins, Evolution and Progress

The origins of process R&D in the pharmaceutical industry go back to the 19th century, when companies started developing efficient industrial processes for the manufacture of new pharmaceuticals. Since then the historical development has broadened and this review examines the progress into the 21st century. Issues such as the increasing complexity of modern drugs, and how this is reflected in the manufacturing strategy, particularly concerning outsourcing, are discussed. The issues of chemical process safety and environmental impact of drug synthesis are paramount in the 21st century, and this places additional constraints on the process chemist and engineer.

The last 20 years has seen great changes in the way process R&D is carried out, with much more emphasis on process understanding, efficient optimisation and knowledge of by-products in all reactions. The tighter limits for new drugs mean that in-process controls as well as final product analytical methods need to be available if products are to be consistently produced within specification.

In 2011 we can say that process R&D has now gained maturity and academic respectability, with its own journal and many books devoted to the subject, as well as some university departments devoted to this important area. In the future, it is expected that academic interest will increase, especially in Asia, where much of the process R&D, under outsourcing arrangements, looks likely to be carried out.