Maxicaps® MR2 Virosart® HF

Application:

• Virus clearance: Virosart® HF targets the removal of both small non-enveloped viruses (20 nm) e.g. PPV, MVM and larger enveloped viruses (> 50 nm) e.g. MuLV from biopharmaceutical feed streams.
• Target molecule: The main application for Virosart® HF filters is the virus filtration of monoclonal antibodies (mAbs), antibody fragments (Fab) or small recombinant proteins (< 150 kD).
• Positioning: Virosart® HF is used towards the end of the purification process of biopharmaceutical products for the virus filtration. At this stage, the purity of the biopharmaceutical product is at its highest and so fouling of the filter by contaminants (DNA, CHOP, aggregates & lipoproteins) will be low.
• Large scale processing: Fully single-use processes at large scale require a pre-sterilized virus filter solution that can also be connected aseptically. Since commercial manufacturing may utilize multiple virus filter elements simultaneously the operational risks and complexity during system setup increase. The plug-and-play integration of Maxicaps® MR Virosart® HF and Virosart® Media into large scale single-use operations as pre-assembled and pre-sterilized filtration unit, minimizes the risk of connection errors and process contamination. Maxicaps® MR Virosart® comes as one closed system with one central venting line.

Product Benefits:

• Robust virus clearance: Virosart® HF retains ≥ 4 LRV of small non-enveloped viruses (e.g. PPV, MVM) and ≥ 6 LRV of large enveloped viruses (e.g. MuLV). This filter offers highest virus safety over the entire flow decay profile independently of operating pressure.
• Short processing times: Based on a unique modified PES membrane, Virosart® HF provides highest flow rates and excellent capacity.
• Smart process transfer: The hollow fiber format supplies highest consistency and scalability from lab to process scale.
• Cost efficiency: The high packing density of the elements combines extremely low hold up and flushing volumes with low footprint requirements.
• Ready to use: The sterile delivery secures ease of use as well as fast installation of the filter elements.
• Ease of use: Virosart® HF are tested for integrity using a water-based diffusion test, e.g. based on the Sartocheck® technology of Sartorius Stedim Biotech

Regulatory Compliance

• Each individual module is tested for integrity and for water flow rate during manufacturing
• Validated for ≥ 4 LRV removal 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 requirements for WFI quality standards set by the current USP
• Non pyrogenic according to USP Bacterial Endotoxins
• USP Plastic Class Test VI