Virus Filters
Viral safety is a key concern in biomanufacturing and is essential to assuring drug safety for patients. For more than two decades, our Viresolve® Pro solutions have set the industry standard in viral safety providing reliable virus retention and cost-effective filtration operations. Viresolve® Pro Solutions provide flexible templates for virus filtration in monoclonal antibodies (mAbs) and recombinant protein production
Key Benefits and Features
Leveraging our global quality systems and the Emprove® Program, our Viresolve® Pro Solutions come with extensive documentation and regulatory support, facilitating your risk assessment and process control.
Two layers of asymmetric polyethersulfone (PES) membrane that enables high flow rates.
Reliable performance across a broad range of operating conditions with log reduction values (LRVs) ≥ 4.0 for small, non-enveloped parvovirus.
Simple installation, operation and integrity testing from pilot to full-scale manufacturing.
Virus Filtration Solutions for Typical and More Challenging Molecules
Viresolve® Pro Solutions provide flexible templates for virus filtration in monoclonal antibodies (mAbs) and recombinant protein production and deliver effective virus retention, high flux and capacity to improve your process efficiency. These solutions include membrane prefilters to remove protein aggregates that reduce virus filter capacity.
Typical mAbs
Viresolve® Pro Solution includes the Viresolve® Pro Device and adsorptive prefilters, Viresolve® Pro Shield and Viresolve® Pro Shield H. This well-established filtration solution provides effective virus retention, high flux and capacity, and consistent batch-to-batch performance for most mAbs and recombinant proteins across process development, clearance studies, and commercial manufacturing.
- Viresolve® Pro Device: Virus retentive filter. 100% integrity tested during manufacturing
- Viresolve® Pro Shield Prefilter: Surface modified membrane prefilter with cation-exchange adsorptive chemistry
- Viresolve® Pro Shield H Prefilter: Surface modified membrane prefilter with mixed-mode adsorptive chemistry
More Challenging Molecules
Viresolve® Pro-S Solution is an advanced filtration solution designed for challenging process fluids, including hydrophobic or high-concentration molecules, providing effective virus retention and enhanced processing. It includes the Viresolve® Pro-S Device and Viresolve® Pro-S Shield and Shield H prefilters for process development and clearance studies.
- Viresolve® Pro-S Device: Virus retentive filter. 100% integrity tested during manufacturing
- Viresolve® Pro-S Shield: surface modified membrane filter with cation-exchange adsorptive chemistry
- Viresolve® Pro-S Shield H: surface modified membrane filter with mixed-mode adsorptive chemistry
Reliable Virus Filtration
The Viresolve® Pro virus filtration solutions offer options for effective virus filtration of any mAb or recombinant protein molecule. Each of these solutions will provide the clearance capabilities you rely on to assure product safety. Further details listed below.
Simplifying Compliance
The Viresolve® Pro Solution is backed by the Emprove® Program – offering product-specific testing data, quality statements and regulatory information to support different stages of development and manufacturing. The Emprove® Program simplifies your compliance needs.
Process Development Service
Optimizing virus filtration involves assessing multiple parameters for reliable, efficient and cost-effective operations. We work side-by-side with engineers and manufacturers to streamline their filtration step. For help with process development, reach out to Tech Service.
Viral Clearance Services
At Bioreliance® Contract Testing our viral clearance studies are designed and executed by regulatory and virology experts ensuring compliance for IND and BLA studies across global facilities in Singapore, China, the U.S., and the UK. We minimize risk and accelerate your market readiness.
Frequently Asked Questions
How do I know which Viresolve® Pro Solution is best for my molecule?
Selecting which virus filter depends on both your molecule and process needs. For most standard mAbs, Viresolve® Pro Solution is the preferred option and will provide high virus retention and excellent filter flux and capacity for a broad range of molecules and operating conditions. For molecules that may have high concentration, hydrophobicity or other biochemical characteristics that are challenging for efficient virus filtration, Viresolve® Pro-S Solution would be the recommended option. Our process development engineers and MSAT teams are available to help you evaluate options and optimize your process.
Can I sterilize Viresolve® Pro and Viresolve® Pro-S Devices and Prefilters?
No, the Viresolve® Pro Solution should be caustic sanitized – this includes both the Device and prefilters. Viresolve® Pro-S Solution is only available in gamma-irradiated presterilized formats. Although stable through pH 9 for standard bioprocessing applications, the low protein binding Viresolve® Pro-S surface chemistry is not caustic stable.
Which filter is best for a high concentration mAb?
For a high concentration mAb we would recommend you evaluate Viresolve® Pro-S Solution first. Performance on any filter will depend on multiple factors including concentration, hydrophobicity, buffer characteristics, etc. Both filters will provide reliable and effective virus retention.
Do I need to use prefilters for both Viresolve® Pro and Viresolve® Pro-S Solutions?
Yes, prefilters are generally recommended for any virus filtration operation and improve capacity and process consistency by reducing the impacts of batch-to-batch variability. Although the low protein binding chemistry of Viresolve® Pro-S Solution is less susceptible to adsorptive fouling, we still recommend using the Viresolve® Pro-S membrane prefilters to maximize filter capacity and maintain flux.
What are the differences between Viresolve® Pro and Viresolve® Pro-S Solution prefilters?
Two membrane prefilters are offered for each of the Viresolve® Pro and Viresolve® Pro-S Solutions: Viresolve® Pro Shield and Shield H prefilters for the Viresolve® Pro Device, and Viresolve® Pro-S Shield and Shield H prefilters for the Viresolve® Pro-S Device. These prefilters have different operating ranges so you can use these to easily select your prefilter based on your process characteristics.
Related Webinars
Related Videos
Related Articles
- Synthetic depth prefilters improve virus filter performance for diverse mAb formats, improving throughput, efficiency, and yield.
- Viresolve® Pro offers reliable viral clearance, high capacity and flux. For difficult-to-filter antibodies, Viresolve® Pro-S boosts filtration efficiency.
- Optimize virus filtration performance with the right prefilters. Learn how fluid characteristics and adsorptive technologies improve capacity and efficiency.
Related Documents
- Data Sheet: Viresolve® Pro-S Solution
Datasheet detailing enhanced throughput for challenging fluid streams and filtration of complex molecules, addressing evolving needs of antibody manufacturers.
- Data Sheet: Viresolve® Pro
Proven viral safety solution designed to provide the highest levels of retention assurance and productivity.
- Application Note: Scalability of the Viresolve® Pro Solution Using the Micro 40 Scaling Tool
This report highlights the consistent scalability and performance of the Viresolve® Pro devices across various scales.
- Application Note: How Baseline Studies Can Ensure Successful Virus Filtration Spiking Studies
Demonstrating the viral clearance capabilities of specific unit operations in downstream processing is a key component of regulatory submissions for biopharmaceuticals.
- Application Note: Virus Retention Performance of Viresolve® Pro Devices under a Range of Processing Conditions
This document outlines virus filtration retention using Viresolve® Pro devices, adhering to the Quality by Design (QbD) terminology for improved process understanding.
- Application Note: Multi-tier Approach to Assuring Virus Retention and Integrity of Viresolve® Pro Devices
Biopharmaceutical manufacturers must characterize key process steps for their ability to clear viruses.
- Article: Virus Filtration Process Development Optimization
The key to a more efficient and cost-effective step.
- Flyer: Viresolve® Pro Solution: Robust Productive, Proven
The Viresolve® Pro Solution is tailored to meet specific needs, offering robust, productive, and proven virus filtration performance.
