Disposable chromatography in antibody manufacturing: The good the bad and the ugly

BIOT 475

Uwe Gottschalk, Uwe.Gottschalk@sartorius.com, VP Purification Technologies, Sartorius AG, Weender Landstr. 217, Goettingen, 37075, Germany
Virtually everything in bioprocessing can be made disposable and its implementation is simply a matter of overall process economy. With state of the art cost models and simulation tools disposable strategies can be easily assessed. Economy of scale effects allow for viable solutions in single use unit operations such as in buffer preparation and storage, harvesting, concentration and also chromatography. In chromatography disposability is at the doorstep. Polishing steps – operated in flow-through mode – are going to be dominated by membrane chromatography devices and provide the basis for two column processes – the next paradigm shift in bioseparation. The presentation will focus on case studies to assess the technical and economical feasibility of disposable unit operations in biomanufacturing.