ABSTRACT
In the development of a biopharmaceutical product there comes a point when the manufacture of product moves from the development phase to manufacturing under the control of good manufacturing practices (GMPs). It is at this stage that the manufacturer has to decide whether to provide a dedicated manufacturing facility (for a single product) or use an existing facility in a multiuse mode (for several products). This decision is more than likely approached from a financial perspective. In doing so there are major regulatory requirements to deal with, particularly with respect to the control of cross-contamination via working areas, equipment, air, and personnel, plus the avoidance of mix-ups when more than one product is being manufactured at any one time.
