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Related Experiment Videos

New Q membrane scale-down model for process-scale antibody purification.

Joe X Zhou1, Tim Tressel, Uwe Gottschalk

  • 1Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. joez@amgen.com

Journal of Chromatography. A
|September 13, 2006
PubMed
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Sartobind Q membrane adsorbers offer competitive capacity for antibody production. A new scale-down model improved throughput and achieved process capacity equivalence, validated by a virus study.

Area of Science:

  • Biotechnology
  • Chemical Engineering
  • Biopharmaceutical Manufacturing

Background:

  • Process-scale antibody production demands high throughput and operational robustness in purification.
  • Traditional Q column chromatography is a standard polishing step.
  • Membrane adsorbers present a potential alternative for improved efficiency.

Purpose of the Study:

  • Evaluate Sartobind Q membrane adsorbers as an alternative to Q column chromatography for process-scale antibody purification.
  • Investigate and address operational issues in current membrane scale-down models, specifically backpressure.
  • Develop a new scale-down model to achieve equivalent process capacity at both small and large scales.

Main Methods:

  • Compared capacity of large-scale membrane adsorbers with column chromatography.

Related Experiment Videos

  • Analyzed operational issues in existing membrane scale-down models, focusing on backpressure effects.
  • Designed and implemented a novel scale-down model mimicking large-scale capsule liquid flow.
  • Conducted a 4-model virus study using the redesigned Sartobind Q absorber scale-down model.

    • Main Results:

    • Large-scale membrane adsorber capacity was competitive with column chromatography.
    • Current scale-down models did not achieve equivalent throughput to large-scale operations.
    • The new scale-down model successfully achieved equivalent process capacity at both scales.
    • The redesigned membrane adsorber scale-down model demonstrated effectiveness in a virus study.

    Conclusions:

    • Sartobind Q membrane adsorbers show promise for process-scale antibody production.
    • A novel scale-down model is crucial for accurately predicting large-scale membrane adsorber performance.
    • The developed scale-down model enables reliable process development and validation for membrane-based purification.