New Q membrane scale-down model for process-scale antibody purification.
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.
Zhou
Joe X
JX
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. joez@amgen.com
Tressel
Tim
T
Gottschalk
Uwe
U
Solamo
Felix
F
Pastor
Andre
A
Dermawan
Shinta
S
Hong
Tony
T
Reif
Oscar
O
Mora
Jeff
J
Hutchison
Fred
F
Murphy
Michael
M
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
D000906:Antibodies; D008567:Membranes, Artificial