Bioseparations: Membrane Processes

Membrane unit operations play a major role in all biotechnology manufacturing processes. During the last two decades, new membranes, modules, and systems have been developed specifically to meet the requirements of the biotechnology industry. Sterile filtration membranes are used to remove insoluble aggregates throughout the downstream process and to ensure sterility in final filling operations. Tangential flow microfiltration is used to harvest secreted protein from cell culture. Depth filtration is used for clarification to remove cell debris. Virus filtration is used to remove endogenous retrovirus-like particles and adventitious viruses as part of the overall viral clearance strategy. Ultrafiltration is used for product concentration, buffer exchange, and formulation. New membrane systems have also been developed for protein-protein separations using high-performance tangential flow filtration and membrane chromatography. This article reviews recent developments in membrane technology, focusing on the development and application of highly effective membrane systems for the commercial production and purification of recombinant protein products.