Challenges in the development of an efficient enzymatic process in the pharmaceutical industry

Despite the unparalleled opportunities that have emerged for biocatalysis over the last few years, there still exist challenges that will hinder the development of an efficient enzymatic process in the pharmaceutical industry. The challenges that will be described in this report include the throughput of an enzymatic process, downstream processing issues, and competition from other toolboxes. Perspectives on economic and intellectual property issues as well as the dynamics surrounding drug intermediates that fall into different stages of the overall drug development process will also be highlighted. Finally, literature examples will be used to offer solutions to those barriers faced by enzymatic processes attempting to transition into manufacturing scale. (C) 2004 Elsevier Ltd. All rights reserved.