《A new Q membrane scale-down model for process-scale antibody purification》.pdfVIP

Journal of Chromatography A, 1134 (2006) 66–73 New Q membrane scale-down model for process-scale antibody purification a,∗ a b a b a Joe X. Zhou , Tim Tressel , Uwe Gottschalk , Felix Solamo , Andre Pastor , Shinta Dermawan , Tony Hong a , Oscar Reifb , Jeff Morab , Fred Hutchisonb , Michael Murphyb a Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA b Sartorius Inc., Weender Landstrasse 94-108, 37075 Goettingen, Germany Received 18 April 2006; received in revised form 16 August 2006; accepted 17 August 2006 Available online 11 September 2006 Abstract Process-scale antibody production requires polishing steps with extremely high product throughput and robust operation. In this communication, the Sartobind Q membrane adsorber for process-scale antibody production is evaluated as an alternative to Q column chromatography. Although the capacity seen with large-scale membrane adsorbers is competitive with column chromatography, the same throughput is not achieved with the current scale-down models. The operational issues currently found in membrane scale-down models, including backpressure, which significantly compromises the membrane’s capacity, were examined. A new scale-down model was designed to mimic the liquid flow path found in the large- scale capsule, and a new process capacity equivalent at both small and large scale was successfully achieved. Results of a 4-model virus study with a redesigned Sartobind Q absorber scale-down model at the new process capacity are presented. © 2006 Elsevier B.V