Maxicaps® MR3 Virosart® Media

Application:

• Target molecule: The main application for Virosart® Media is virus retentive filtration of chemically defined cell culture media.
• Virus clearance: Virosart® Media targets the removal of small non-enveloped adventitious viruses (20 nm) e.g. MVM or vesivirus from chemically defined cell culture media.
• Positioning: Virosart® Media is used after the media preparation step itself before transferring the media into the bioreactor. This can be operated either as in-line filtration (e.g. perfusion) or batch filtration. Performance of the Virosart® Media is independent of the use of powder or liquid media but could be strongly impacted by the media itself. Virosart® Media is optimized for chemically defined media. Protein transmission for mAbs and recombinant proteins is not given for this filter.
• 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® Media provides high virus safety to the bioreactor as it is qualified for ≥ 4 LRV (Log10 reduction value) of small non-enveloped viruses (e.g. MVM) and ≥ 6 LRV for large enveloped viruses.
• Short processing times: Based on the optimized Polyethersulfone membrane, Virosart® Media provides highest flow rates and excellent capacity for cell culture media (e.g. ≥ 1000 L/m2 in 4 h).
• 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 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® Media 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