Virosart CPV
PES-based virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in biopharmaceutical applications. Virosart® CPV is the optimal virus filter for monoclonal antibodies or small recombinant proteins.
Product Code: 5457328V2
Application
Virus clearance: Virosart® CPV retains ≥ 4 LRV of small non-enveloped viruses (e.g. PPV, MVM) and ≥ 6 LRV of large enveloped viruses (e.g. MuLV).
Target molecule: The primary applications of Virosart® CPV for virus filtration are monoclonal antibodies (mAb), antibody fragments (Fab), or small recombinant proteins (< 150 kD).
Positioning: Virosart® CPV is used toward the end of the purification process of biopharmaceutical products for virus filtration. At this stage, the purity of the biopharmaceutical product is at its highest level, and therefore fouling of the filter by contaminants (DNA, CHOP, aggregates, and lipoproteins) will be low.
Product Benefits
Robust virus clearance: Virosart® CPV retains ≥ 4 LRV of small non-enveloped viruses (e.g. PPV, MVM) and ≥ 6 LRV of large enveloped viruses (e.g. MuLV). This filter provides the highest virus safety across the entire flow decay profile regardless of operating pressure.
Smart process transfer: Flexibility is achieved using cartridges in existing stainless steel housings or single-use capsules.
Ease of use: Virosart® CPV is integrity-tested using a water-based diffusion test, e.g. based on Sartorius Stedim Biotech's Sartocheck® technology.
Regulatory Compliance
- Each filter is integrity tested
- Validated for removal of ≥ 4 LRV of small non-enveloped viruses using bacteriophage PP7
- Designed, developed, and manufactured in accordance with an ISO 9001 certified Quality Management System
- Meet or exceed the WFI quality standard requirements specified by the current USP
- Non-pyrogenic according to USP Bacterial Endotoxins
- USP Plastic Class Test VI
