Hybrid and disposable facilities for manufacturing of biopharmaceuticals: pros and cons.

Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.In this chapter, four case studies are presented which outline ways to reduce significantly R&D and manufacturing costs by using disposable technology in the frame of a the transfer of an antibody manufacturing process, the preparation of media and buffers in commercial manufacturing and a direct comparison of a traditional and a fully disposable pilot plant.