Biotechnology in bulk drug production. Objectives and strategies of process development.

Modern biotechnology has an increasing importance especially in waste water treatment and drug production. Depending on the product added values, the objectives of process development differ in degree and importance. For the production of bulk pharmaceutical chemicals these objectives are basically: product safety and operation reliability (concerning levels of sterile engineering and containment categories); short development time and ease of process validation; process economics and flexibility of production. The present paper evaluates these objectives at different boundary conditions and discusses the parameters of process performance and the potential for biological and technical improvements which may be achieved by process development. These considerations help to determine the strategies of process development: to select the appropriate process technologies and to assign the resources for research and development.