Basic Concepts in Q Membrane Chromatography for Large-Scale Antibody Production

摘要

The large-scale production of recombinant human monoclonal antibodies demands economical purification processes with high throughputs.In this article we briefly describe a common antibody process and evaluate the Q membrane adsorber for process-scale antibody production as an alternative to a Q-packed-bed column in a flow-through mode.The scientific concepts underlining Q membrane technology and its application are reviewed.The disadvantages and advantages of using Q membrane chromatography as a purification unit in large-scale production are discussed,including problems initially seen with the Q membrane scale-down model but solved with the invention of a new scale-down model.The new Q-membrane unit operation has a process capacity greater than 3000 g/m~2 or 10.7 kg/L with a LRV over 5 for four model viruses.In this Review,a cost analysis illustrates that Q membrane chromatography is a viable alternative to Q column chromatography as a polishing step in a flow-through mode for process-scale antibody production.