Virosart® HF: High-Flux Virus Filtration for mAbs and Recombinant Proteins

High-Speed Virus Filtration with Virosart® HF

Virosart® HF is a state-of-the-art solution for high-speed virus filtration. It is specifically designed for monoclonal antibodies (mAbs), antibody fragments (Fab), and small recombinant proteins. Its advanced polyethersulfone (PES) membrane delivers high flow rates and capacity under various processing conditions.

Virosart® HF supports robust processing by efficiently retaining both small non-enveloped viruses like MVM (LRV ≥ 4 log₁₀) and large enveloped viruses such as MuLV (LRV ≥ 6 log₁₀) from biopharmaceutical feed streams, safeguarding the integrity and quality of your product.

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Challenges in Virus Clearance

Contamination of products derived from human or animal cells with viruses can have serious clinical consequences. As a result, regulatory authorities emphasize the need for robust and orthogonal virus clearance strategies. Virus filtration has long been recognized as a reliable and effective method for achieving virus clearance.

Virus Filtration Strategy for mAbs

Virosart® HF combines robust virus retention with high capacity for mAbs and recombinant proteins. It is specifically designed for easy integration into single-use processes, featuring a smart capsule design, compact footprint, and low flushing volumes.

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Product Overview

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Performance Deep Dive

Details of Virosart® HF

Target Molecule
The main application for Virosart® HF, for virus retentive filtration, are monoclonal antibodies (mAbs), antibody fragments (Fab) or small recombinant proteins (< 150 kD).

Positioning
Virosart® HF is used towards the end of the purification process for viral filtration of the biopharmaceutical product.

Working Principle
Virus filtration works based on sizes exclusion. Small non-enveloped and large enveloped viruses are retained by the asymmetric membrane structure.

Virus Removal

  • State of the art, robust virus removal performance
  • ≥ 4 log10 for small non-enveloped viruses
  • ≥ 6 log10 for large enveloped viruses

Cost Efficiency

  • Capsule design avoids costly investments in stainless-steel filtration systems and accessories
  • High filter packaging density decreases cleanroom footprint

Handling

  • Includes a convenient water based integrity test to ensure reliability
  • Sterile shipping options help to advance bioburden risk mitigation

Technical Proof

Retentive Capacities

The Virosart® HF delivers reliable virus removal under all circumstances with no impact from pressure variations, high loads, or process interruptions.

Performance

The Virosart® HF features high flux (340 LMH @ 2 bar) and superior capacity (>7 kg/m²), and can be optimized by a Virosart® Max pre-filter, as needed.

Poster

Integration of Single-Use Virus Filters in Stainless-Steel Facilities

Gain insights | practical guidance for implementing hybrid virus filtration solutions in existing stainless-steel facilities.

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Knowledge Base

Download Library

Publication

Continous Processing: Challenges and Opportunities of Virus Filtration

PDF | 285.8 KB
Application Note

Virosart® HF: High Speed Virus Filtration for mAbs and Recombinant Proteins

PDF | 3.0 MB
Application Note

Effect of Pressure Release on Virus Retention - Virosart® HF

PDF | 863.5 KB
Application Note

Risk Mitigation for Calcium Chloride Solution as an Additive to Cell Culture Media Using High Flux Virus Filters

PDF | 761.7 KB
Poster

Virus Filtration Under Challenging Conditions

PDF | 379.6 KB
Poster

Virus Filters Enabling Reliable Process Development in Antibody Processes

PDF | 314.5 KB
Poster

Increasing Virus Filter Throughput by Process Optimization Studies

PDF | 873.1 KB
Poster

Robustness Study for Virus Filtration of mAb Processes

PDF | 878.9 KB
Poster

Concept of a Fully Single-Use Virus Filtration

PDF | 973.2 KB
Datasheet

Virosart® HF - High Speed Virus Filtration for mAbs and Recombinant Proteins

PDF | 1.1 MB
Flyer

Virosart® Virus Filters - Reliable Retention Under All Circumstances

PDF | 528.4 KB

Training Videos

Tutorial

Virosart® HF Lab Module Product Tutorial

Discover the steps to effectively install and execute virus filtration trials. Gain valuable insights to enhance your filtration process.

Tutorial

Virosart® HF Process Module Product Tutorial

Learn the installation and execution of virus filtration at commercial scale with the expert handling tips in our comprehensive guide.

Webinars

Webinar

Sartorius End-to-End Single-Use Downstream Solutions

Discover how our latest single-use technologies address the evolving demands of clinical and commercial biopharmaceutical production.

Webinar

Optimizing Virus Clearance With Anion Exchange Membranes

Explore best practices for sizing and optimizing anion exchange membrane adsorbers to enhance purification performance.

Webinar

Virus Removal in Blood and Plasma Manufacturing

Understand how emerging viruses challenge traditional risk mitigation approaches—and how Sartorius supports improved virus clearance strategies.

Webinar

Filtration Technologies - An Overview

Explore comprehensive and reliable solutions for virus filtration across bioprocess workflows.

Webinar

Process Optimization Strategies for Virus Filtration

Learn about validation strategies and best practices for integrity testing of virus filters and adsorptive pre-filters.

Supporting Products & Services

Virosart® Max: An Adsorptive Virus Pre-Filter

Enhance virus filtration by protecting the final filter using a combination of size exclusion and adsorptive mechanisms.

Large Scale Single-Use Virus Filtration

Maxicaps® MR Virosart® for large scale filtration eliminates 90% formerly needed tubings | connections and minimizes risks and installation efforts.

Virus clearance validation services

Confidence®: Faster LRV Results

Validate the performance of Virosart® virus filters with our Confidence® Services. Benefit from highly purified viruses and expert knowledge.

Extractables and Leachables Testing

Ensure the safe adoption of single-use systems in biopharmaceutical processes.

Advance Your Virus Filtration Process

Achieve robust retention, enhanced efficiency, reduced contamination risk, and flexible configuration options.

Frequently Asked Questions

The Virosart® HF virus filter is used for virus filtration in biopharmaceutical applications, specifically designed to remove both small non-enveloped viruses and larger enveloped viruses from monoclonal antibodies, antibody fragments, and small recombinant proteins.

The Virosart® HF filter can effectively remove small non-enveloped viruses, such as PPV and MVM, and large enveloped viruses, such as MuLV, ensuring robust virus clearance.

The Virosart® HF filter is available in various formats, including lab, mid-scale, and process modules, with filtration areas ranging from 0.2 m² to 14.4 m², catering to different scales of development and production.

The Virosart® HF filter uses a modified polyethersulfone (PES) membrane that provides high flow rates and capacity, ensuring rapid processing and minimal hold-up volumes, which helps maintain product integrity throughout the filtration process.

Yes, the Virosart® HF filter is designed for ease of use and quick installation. It is delivered sterile, facilitating straightforward integration into biopharmaceutical processes, and is compatible with Sartocheck® technology for integrity testing.

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