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 3,000 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.
Zhou
Joe X
JX
Department of Purification Process Development, AMGEN Inc., One Amgen Center Drive, Thousand Oaks, California 91320, USA.
Tressel
Tim
T
D000818:Animals; D000906:Antibodies / Q000302:isolation & purification*; D002845:Chromatography / Q000191:economics / Q000379:methods*; D006801:Humans; D008954:Models, Biological; D013696:Temperature; D013997:Time Factors; D014783:Viscosity
D000906:Antibodies