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Recovery modeling of tangential flow systems
Suma Rao1, Eva Gefroh, Oliver Kaltenbrunner
1Purification Process Development, Amgen Inc., Mail Stop 30W-2-A, One Amgen Center Dr., Thousand Oaks, California 91320, USA. sumar@amgen.com
Biotechnology and Bioengineering
|June 13, 2012
Summary
Existing tangential flow filtration (TFF) systems struggle with higher protein therapeutic concentrations. This study presents a systematic approach and new engineering diagrams to assess TFF system operational limits for process fit evaluations.
Area of Science:
- Biopharmaceutical Manufacturing
- Chemical Engineering
- Process Development
Background:
- Increasing demand for higher protein therapeutic concentrations strains existing tangential flow filtration (TFF) systems.
- TFF is crucial for buffer exchange and concentrating drug substances, but current systems were designed for lower concentrations.
- Evaluating TFF systems outside original design specifications presents challenges.
Purpose of the Study:
- To present a systematic approach for assessing the operational limits of TFF processes.
- To develop new engineering diagrams for evaluating TFF system performance under changing process targets.
- To provide a rational basis for TFF system upgrades and new system design specifications.
Main Methods:
- Development of a systematic approach to assess TFF system operational limits.
- Introduction of two novel engineering diagrams: the recovery efficiency diagram and the operating space plot.
- Relating operational constraints and parameters within these diagrams for rapid process fit evaluation.
Main Results:
- The proposed engineering diagrams integrate all relevant operational constraints and parameters.
- These diagrams facilitate rapid assessment of TFF system suitability for new process targets.
- The analysis provides a rational method for reviewing system limitations.
Conclusions:
- The engineering assessment method enables rational review of existing TFF system limitations.
- It supports targeted system upgrades for inadequate existing systems.
- Provides a basis for setting design specifications for new TFF systems.
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