高速過濾病毒
Virosart? HF具有最高水平的病毒安全性，對單克隆抗體、抗體片段或小重組蛋白具有靈活的病毒截留過濾能力。該過濾器主要針對MVM和水皰疹病毒等非包膜病毒，以及MuLV等大型包膜病毒，全覆蓋了提升工藝質(zhì)量所需的一切范圍。
病毒安全的挑戰(zhàn)
源自人或動物細胞的產(chǎn)品受到病毒污染會帶來災(zāi)難性的臨床后果。因此，監(jiān)管機構(gòu)強調(diào)需要實施穩(wěn)健和正交的病毒清除策略。傳統(tǒng)上認為病毒過濾是病毒清除的有效方法。
適用于單克隆抗體的策略
Virosart? HF具有最高的病毒安全性，對單克隆抗體和重組蛋白具有優(yōu)越的性能。該過濾器特別設(shè)計成易于整合到一次性工藝中，具有智能囊式設(shè)計、占用空間較小并且沖洗量最小。
Virosart? HF詳情
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
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