Single-use technology supporting the comeback of continuous bioprocessing

Abstract

By many measures biotechnology recently celebrated its 30th anniversary. The current dominance of the fed-batch culture of suspension cells in manufacturing of biopharmaceuticals often obscures its robust history of process development. One interesting theme, for protein biologicals especially, is the waxing and waning of a variety of approaches to continuous processing. In fact, a number of implementations of this mode of production have long been in use by such well-known pharmaceutical manufacturers as Genzyme (Sanofi) and Centocor (Johnson & Johnson/ Janssen) to make highly successful products, such as Cerezyme® and Remicade®. Interest in continuous bioprocessing (CB) is growing of late due to a number of economic, technological and regulatory developments. Features provided by single-use bioproduction systems complement those provided by CB methods, and the number of operations supported by them is large and growing.