高速过滤病毒
Virosart® HF具有最高水平的病毒安全性，对单克隆抗体、抗体片段或小重组蛋白具有灵活的病毒截留过滤能力。该过滤器主要针对MVM和水疱疹病毒等非包膜病毒，以及MuLV等大型包膜病毒，全覆盖了提升工艺质量所需的一切范围。
病毒安全的挑战
源自人或动物细胞的产品受到病毒污染会带来灾难性的临床后果。因此，监管机构强调需要实施稳健和正交的病毒清除策略。传统上认为病毒过滤是病毒清除的有效方法。
适用于单克隆抗体的策略
Virosart® HF具有最高的病毒安全性，对单克隆抗体和重组蛋白具有优越的性能。该过滤器特别设计成易于整合到一次性工艺中，具有智能囊式设计、占用空间较小并且冲洗量最小。
Virosart® HF详情
Target Molecule
The main application for Virosart® HF, for virus retentive filtration, are monoclonal antibodies (mAbs), antibody fragments (Fab) or small recombinant proteins (< 150 kD).
Positioning
Virosart® HF is used towards the end of the purification process for viral filtration of the biopharmaceutical product.
Working principle
Virus filtration works based on sizes exclusion. Small non-enveloped and large enveloped viruses are retained by the 20 nm asymmetric membrane structure.
Virus Risk Mitigation
- State of the art, robust virus removal performance
- ≥ 4 LRV for small non-enveloped viruses
- ≥ 6 LRV for large enveloped viruses
Cost Efficiency
- 3x capacity increase at high flow rates and reduced flushing buffer volume deliver a cost efficient solution
- Capsule design avoids costly investments in stainless steel filtration systems and accessories
- High filter packaging density decreases cleanroom footprint
Handling
- Includes a convenient water based integrity test to ensure reliability
- Sterile shipping options help to advance bioburden risk mitigation
技术证明
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