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Design considerations impacting flow dynamics in packed beds for virus inactivation.
Innara Basria1, Opeyemi Ajayi2, Madaisabel FuentesArias1
1Division of Pharmaceutical Quality Research VI (DPQR VI), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Quality Research (OPQR), Silver Spring, Maryland, USA.
Biotechnology Progress
|January 10, 2026
Summary
Continuous virus inactivation (CVI) using packed bed reactors (PBRs) faces challenges. Tracer size affects minimum residence time (mRT) prediction, and scale-up issues were observed, impacting virus inactivation efficacy.
Area of Science:
- Biopharmaceutical Manufacturing
- Chemical Engineering
- Process Chemistry
Background:
- Continuous manufacturing of monoclonal antibodies is advancing.
- Continuous virus inactivation (CVI) implementation faces standardization challenges, impacting product quality and safety.
- Minimum residence time (mRT) prediction in packed bed reactors (PBRs) for CVI is not well-established.
Purpose of the Study:
- To characterize residence time distribution (RTD) in PBRs for CVI.
- To evaluate the impact of tracer molecular properties on mRT prediction.
- To assess scale-up effects on mRT in PBRs for CVI.
Main Methods:
- Utilized four PBR configurations.
- Characterized RTD using tracers with varying molecular sizes.
- Analyzed mRT prediction under different conditions and scale-up scenarios.
Main Results:
- Tracer molecular size significantly impacted mRT prediction; larger molecules exhibited shorter residence times.
- Scale-up from 16 to 26 mm diameter columns did not maintain mRT.
- Traditional chromatography scale-up principles may not directly apply to PBR-based CVI.
Conclusions:
- Process material properties, particularly molecular size, influence mRT prediction in PBRs for CVI.
- Scale-up strategies need re-evaluation for CVI PBRs.
- Understanding these factors is crucial for effective virus inactivation in integrated continuous manufacturing systems.
