High Speed Virus Filtration
Virosart® HF combines the highest level of virus safety with flexible capacities for virus retentive filtration of monoclonal antibodies, antibody fragments or small recombinant proteins. The filter targets both non-enveloped viruses, such as MVM and vesivirus, and large enveloped viruses, such as MuLV, providing the full range of coverage needed to enhance your process quality.
Challenges in Virus Safety
A contamination of products derived from human or animal cells with viruses can have disastrous clinical consequences. Therefore, regulatory authorities stress the need to implement robust and orthogonal strategies for virus clearance. Virus filtration has traditionally been accepted as a robust method for virus clearance.
Strategy for mAbs
Virosart® HF combines highest virus safety with superior capacities for mAb´s and recombinant proteins. The filter is especially designed for easy implementation into single-use processes with its smart capsule design, low foot print and minimal flushing volumes.
Details of Virosart® HF
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
Technical Proof
Retentive Capacities
The Virosart® HF delivers reliable virus safety under all circumstances with no impact from pressure variations, high loads or process interruptions.
Performance
The Virosart® HF features high flux (340 LMH @ 2 bar) and superior capacity (>7 kg/m²), and can be optimized by a Virosart® Max pre-filter, as needed.
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Application Notes
