《Basic concepts in Q membrane chromatography for large-scale antibody production》.pdf

Biotechnol. Prog. 2006, 22, 341−349 341 REVIEW Basic Concepts in Q Membrane Chromatography for Large-Scale Antibody Production Joe X. Zhou* and Tim Tressel Department of Purification Process Development, AMGEN Inc., One Amgen Center Drive, Thousand Oaks, California 91320 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/m2 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. Contents Antibody Process. A typical large-scale monoclonal antibody purification process is often built around the employment of Introduction 341