New Q membrane scale-down model for process-scale antibody purification |
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Authors: | Zhou Joe X Tressel Tim Gottschalk Uwe Solamo Felix Pastor Andre Dermawan Shinta Hong Tony Reif Oscar Mora Jeff Hutchison Fred Murphy Michael |
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Institution: | Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. joez@amgen.com |
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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. |
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