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Validation and optimization of viral clearance in a downstream continuous chromatography setting
Meng-Jung Chiang1, Mark Pagkaliwangan2, Scott Lute1
1Division of Biotechnology Review and Research II, Office of Biotechnology Products, Office of Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Biotechnology and Bioengineering
|May 22, 2019
Summary
Continuous bioprocessing offers advantages, but regulatory challenges like virus safety must be addressed. This study shows multicolumn continuous chromatography provides similar virus clearance to single-column batch methods, validating scale-down models.
Area of Science:
- Biopharmaceutical Manufacturing
- Process Engineering
- Viral Safety
Background:
- Continuous bioprocessing promises enhanced product consistency, productivity, and cost reduction.
- Transitioning to continuous processing involves overcoming significant business and regulatory hurdles, particularly concerning viral safety.
- Ensuring viral safety requires robust testing and effective virus clearance during purification, with chromatography being a critical unit operation.
Purpose of the Study:
- To evaluate the impact of chromatographic parameter modifications on virus clearance during the transition from single-column batch to multicolumn continuous chromatography.
- To determine if virus clearance in multicolumn continuous operation is comparable to traditional single-column batch processing.
- To assess the predictive capability of single-column experiments for multicolumn continuous system performance regarding virus clearance.
Main Methods:
- A Design of Experiment (DoE) approach was employed to investigate the influence of linear velocity and resin capacity utilization on virus clearance.
- Two model monoclonal antibodies (mAbs) and two bacteriophages (as mammalian virus surrogates) were utilized in the study.
- Virus clearance was assessed in both single-column and multicolumn modes under identified best-case and worst-case conditions derived from the DoE.
Main Results:
- The DoE successfully identified optimal and suboptimal conditions for virus clearance.
- Virus clearance, measured by Log Reduction Values (LRV), was found to be similar between single-column and multicolumn continuous operations.
- Chromatographic parameters impacting viral clearance in single-column mode effectively predicted performance in multicolumn modes.
Conclusions:
- The viral clearance performance of multicolumn continuous chromatography systems is comparable to single-column batch systems.
- Key parameters influencing virus clearance in single-column chromatography are predictive of performance in multicolumn continuous systems.
- These findings support the use of scaled-down single-column models for evaluating the viral clearance capabilities of multicolumn continuous Protein A systems.
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