title: New Q membrane scale-down model for process-scale antibody purification.
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.
authors.affiliation: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. joez@amgen.com
authors.forename: Joe X
authors.initials: JX
authors.lastname: Zhou
authors.forename: Tim
authors.initials: T
authors.lastname: Tressel
authors.forename: Uwe
authors.initials: U
authors.lastname: Gottschalk
authors.forename: Felix
authors.initials: F
authors.lastname: Solamo
authors.forename: Andre
authors.initials: A
authors.lastname: Pastor
authors.forename: Shinta
authors.initials: S
authors.lastname: Dermawan
authors.forename: Tony
authors.initials: T
authors.lastname: Hong
authors.forename: Oscar
authors.initials: O
authors.lastname: Reif
authors.forename: Jeff
authors.initials: J
authors.lastname: Mora
authors.forename: Fred
authors.initials: F
authors.lastname: Hutchison
authors.forename: Michael
authors.initials: M
authors.lastname: Murphy
mesh_terms: D000818:Animals; D000906:Antibodies / Q000302:isolation & purification*; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D006801:Humans; D008567:Membranes, Artificial; D051379:Mice; D008954:Models, Biological; D015203:Reproducibility of Results; D018406:Virus Physiological Phenomena
chemical_list: D000906:Antibodies; D008567:Membranes, Artificial