The role of bioassays in the development, licensing and batch control of biotherapeutics.

The role of bioassays in ensuring the safety and efficacy of medicines produced by biotechnology intended for human use is under continuous review. It is a complex area, in which the rapid scientific and technological advances have been accompanied, more or less synchronously, by novel clinical applications. The need to match the rapidity of these developments with the necessarily more cautious regulatory procedures for licensing and controlling medicines in the pharmaceutical marketplace has produced an area of active debate. This article reviews the debate and its practical consequences, while maintaining the pre-eminence of the underlying scientific values.