Viresolve NFR Filters

Description

Viresolve NFR filters with Retropore® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources. Viresolve NFR filters are ideal for polishing monoclonal antibodies, and provide an easy-to-implement technology that eliminates retrovirus contaminants in essential media and protein feed streams. When placed downstream of a bioreactor, Viresolve NFR filters minimize infection risk caused by viruses common to mammalian cell expression systems.

≥ 6 log removal of retroviruses
> 98% recovery of protein

• Robust processing
  
• Fast alcohol-free integrity testing
  
• Multiple formats available for easy scaling
  
• Each lot is 100% integrity tested

Fast, Reliable Clearance

Cast from polyethersulfone, Retropore membrane exhibits a patented void-free pore structure characterized by superior clearance and high flow rates. Denser internally than on its surface, the asymmetrical matrix of the membrane effectively traps large viruses and efficiently passes smaller proteins.

By providing fast and highly reliable clearance, Viresolve NFR filters improve product safety and protect downstream processes.

High Yields and Product Quality

Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide > 98% protein product yields, while low extractables ensure product quality. Retropore membrane technology passes proteins up to 700 kDa and consistently clears retroviruses at > 6 LRV (Log Reduction Value).

Regulatory Compliance

All Viresolve NFR filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to ISO® 9001. Viresolve NFR capsules and cartridge filters are integrity tested during manufacturing and are supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each filter is shipped with a Certificate of Quality in a sealed bag clearly labeled with the product name and identifying characteristics. Code 7 cartridges come with SMART Technology. This SMART filter has an embedded RFID tag preloaded with Catalogue Number, Lot Number, Serial Number and cartridge specific diffusion value.

Millipore has submitted a Biological Master File to the FDA and will submit it to other worldwide regulatory agencies needed to support customer applications. Please contact Millipore to obtain a Letter of Authorization to reference in your application.

Virus Retention

Pleated filters and OptiScale-25 disposable devices have been extensively tested using the 78 nm diameter Φ6. This bacteriophage is readily grown to monodispersed, uniform size, high titer challenges. A consistent >6.5 LRV has been observed over the range of feedstock and processing conditions shown in Table 2.

Multiple Formats Available

Viresolve NFR with Retropore membrane is available in three formats and multiple configurations that vary by filtration area and the type of inlet/outlet connection. Choose the format that’s right for your process requirements:

• OptiScale®-25 disposable capsule filters
  
• Opticap XL and XLT disposable capsule filters
  
• Cartridge filters

Cartridge Filters

Viresolve NFR 10-, 20- and 30-inch cartridge filters are ideally suited for processes that require maximum pressure differentials. Each cartridge is integrity tested during the manufacturing process. A range of filtration areas is available to suit medium and large volume requirements.