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Deciphering Virus Removal With Ultrafiltration Membrane: Effects of Membrane Properties, Operating Conditions, and
Jiansheng Lu1,2, Shilong Qi3,4, Hui Chen2
1School of Biopharmacy, China Pharmaceutical University, Nanjing, China.
A new virus filtration membrane, UF-Viremoval-Plus, shows superior performance in removing viruses from antibody therapeutics. It maintains stable operation and achieves high virus removal levels, offering insights for biopharmaceutical manufacturing.
Area of Science:
- Biopharmaceutical Manufacturing
- Membrane Science
- Viral Clearance
Background:
- Virus filtration is essential for antibody-based therapeutic safety.
- Limited availability and high cost of biologics restrict studies on virus retention.
- Existing virus filtration membranes have stringent performance requirements.
Purpose of the Study:
- To comprehensively evaluate a novel virus filtration membrane, UF-Viremoval-Plus.
- To benchmark UF-Viremoval-Plus against leading commercial virus filters.
- To investigate the impact of process parameters on membrane performance.
Main Methods:
- Benchmarking UF-Viremoval-Plus against commercial virus filters.
- Evaluation of antifouling properties and virus retention performance.
- Investigation of effects of pH, ionic strength, antibody type, and concentration on membrane flux and virus removal efficiency.
Main Results:
- UF-Viremoval-Plus demonstrated superior antifouling and virus retention compared to commercial filters.
- Consistent virus removal exceeding 4 log reduction value achieved, with no breakthrough.
- Membrane performance was affected by significant shifts in pH, ionic strength, and membrane fouling due to high protein concentrations.
Conclusions:
- UF-Viremoval-Plus offers enhanced virus filtration performance for antibody therapeutics.
- Understanding membrane-protein-virus interactions is crucial for process optimization.
- Provides theoretical insights for designing advanced virus filtration membranes and optimizing biopharmaceutical manufacturing processes.
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