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

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.