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Qualifying and Using Virus Filtration Integrated Into Low- and High-Flux Continuous Processes
This study evaluates the performance of Virosart® HF in combination with Virosart® Max in low flux/ low pressure (15LMH at 2psi) and high flux/ high pressure (350LMH at 40psi) continuous virus filtration processes. Process performance was assessed with a focus on virus retention using PPV. The integration of Virosart® HF virus filters with Virosart® Max adsorptive prefilters demonstrates robust virus retention and high throughput, which are essential for continuous biopharmaceutical manufacturing. The results show consistent performance in both batch and continuous operation modes, supporting effective virus clearance and reliable process performance.
Key Takeaways:
- Robust Virus Retention: Virosart® HF filters, provide effective virus retention in continuous processes which is crucial for maintaining reliability in biopharmaceutical manufacturing.
- Consistent Filtration Performance: These studies demonstrate that Virosart® HF delivers high throughput and low flux decay in both batch and continuous operation modes, ensuring reliable virus filtration.
- Versatile Application: The filters can be integrated into intensified processes using either low-flux or high-flux operation modes, providing flexibility to adapt to different manufacturing configurations.
