ABSTRACT

The objective of this chapter is to provide an industry perspective on the selection criteria for using either the perfusion or the fed-batch techniques as the platform of choice to manufacture biologic products, made by cell culture and to provide an insight into the decision-making process in favor of perfusion-based manufacturing or fed-batch. The specific case described here corresponds to a multi-product facility for initial product development trials (i.e. phase I and phase II). This clarification of scope is important, as each technique is suitable for production of biologics, and the reasons to prefer one over the other as described in this chapter are primarily based on long-term objectives for the facility such as meeting the production requirements of a diverse pipeline rather than on the intrinsic merits of either technique.