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Virus filtration stands as the most robust and reliable operation unit for viral contamination control in biopharma downstream processing.
Since the first launch of Viruclear™ virus removal filter in 2021, Cobetter has developed a comprehensive virus filtration product line featuring PES (polyethersulfone) and RC (regenerated cellulose) membrane materials, with dedicated prefiltration solutions.
This portfolio flexibly addresses the differentiated needs of diverse feed streams, including antibodies, recombinant proteins, blood products, and biochemical extracts. Leveraging a comprehensive product portfolio and deep application expertise, Cobetter provides end-to-end, one-stop virus filtration solutions. This article provides an overview of the Viruclear™ virus removal filter portfolio.
Viruclear™ VF Series – PES Virus Removal Filters
Viruclear™ VF Series is built on PES membrane material, featuring a structure with asymmetric continuous gradient pore, which significantly enhances dirt-holding capacity, allowing the membrane to stably retain both large-particle impurities, such as protein aggregates, and potential viruses. The surface layer on the permeate side consists of a retention layer with a precision of approximately 20 nm, featuring a uniform pore size distribution. This enables robust retention of small viruses and provides reliable performance under extreme filtration challenges, including high/low pressure and process interruptions. The following images show scanning electron microscope (SEM) images of the PES virus removal membrane. The left is a cross-sectional SEM view near the permeate side, and the right is the SEM view of the permeate side surface.
The VF and VF Plus models are primarily used for virus filtration of biologics such as monoclonal antibodies and recombinant proteins. They demonstrate good filtration performance and linear scalability for protein products at low-to-medium concentrations and with good stability. For higher-concentration products or more complex feed streams, VF Plus X is typically the more suitable option, offering enhanced fouling resistance. The unique hydrophilic modification process endows the VF Series virus removal membranes with excellent filtration performance. Combined with the inherent high flux advantage of PES, these membranes deliver outstanding results in processing products including antibody and recombinant protein.
Viruclear™ VF Series filters are supplied in the form of cassette with plastic jacket. Pilot-scale cassettes connect directly to inlet and outlet tubing via TC25 fittings; Production-scale cassettes with greater filtration area (0.5 m² and 1.5 m²), require stainless steel holders for installation. From syringe filters for process development to cassettes for pilot and production scales, the Viruclear™ VF Series demonstrates excellent linear scalability, effectively meeting customer production requirements.
Effective virus retention is fundamental to virus filtration. Viruclear™ VF Series filters are designed to address the virus-clearance requirements of diverse biopharmaceutical feed streams, delivering robust and reproducible virus removal performance. In virus clearance studies, the filters have demonstrated a log reduction value (LRV) of ≥4 under defined test conditions.
Taking the VF Plus virus removal filter as an example (top-right image), robust virus retention maintained across various buffer conditions.
Viruclear™ VF Series Operational Parameters
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Viruclear™ RC Series – RC Virus Removal Filters
Features
- Low protein adsorption, high protein recovery
- Asymmetric membrane structure and the prefiltration layer provide excellent fouling resistance and stable process flow rates
- Tight pore size distribution in the retention layer guarantees reliable virus retention.
- Flat-sheet membrane structure offers mechanical support. ·化学稳定好Excellent chemical compatibility.
Typical Applications
- Coagulation factors
- IVIG
- Biochemical enzymes
- Fusion proteins
- Complex antibody products
Viruclear™ RC Series virus removal filters utilize regenerated cellulose (RC) membrane. Leveraging its inherently excellent hydrophilicity, the membrane achieves lower protein adsorption and higher recovery, while also offering superior fouling resistance. Even when processing challenging products containing hydrophobic proteins, high-content aggregate , or high-level impurity, the filters maintain good filterability (as shown below).
Viruclear™ RC Series features a nominal retention pore size of 20 nm. Based on a size-exclusion mechanism, they efficiently remove virus particles, including small viruses. The standard RC model is suitable for virus filtration of complex antibody products and low-to-medium concentration blood products. The RCH model, with further optimized membrane manufacturing processes, is specifically designed for high-concentration blood products and protein solutions with high fouling propensity. Viruclear™ RC Series serves as a novel solution for applications where Viruclear™ VF Series may not perform optimally, particularly for virus filtration of biologics derived from human plasma, offering customers a more comprehensive solution portfolio. The following images show SEM images of the RC virus removal membrane. The left is a cross-sectional SEM view near the permeate side, and the right is the SEM view of the permeate side surface.
Viruclear™ RC Series virus removal filters are available in two formats: cassettes with silicone jacket preserved in a bacteriostatic solution (2% benzyl alcohol or 20% ethanol solution), and cassettes with rigid plastic jacket preserved in purified water, as shown below.
The rigid plastic version is currently the preferred format due to its ease of flushing (facilitated by water preservation) and its advantage of being sterilized prior to factory release. In addition, the rigid plastic version is also offered as an integrated, self-contained cassette that requires no holder, featuring quick-connect installation, which significantly enhances production convenience and makes it the preferred choice for process scale-up.
Viruclear™ RC Series Operational Parameters
Order Information for Viruclear™ RC
Order Information for Viruclear™ RCH
Viruclear™ Pre-filters
In virus filtration processes, impurities such as protein aggregates in the intermediate feed can adversely impact the performance of virus removal filters. The pre-filter is placed upstream of the core virus removal filter and serves as a critical protective barrier.
It plays a key role in removing protein aggregates and other sub-visible particles from the feed solution, effectively mitigating membrane fouling, extending filtration lifespan, reducing the required virus removal filter membrane area, and ensuring process cost-efficiency.
Cobetter offers a range of variety of virus removal pre-filters based on different mechanisms to accommodate diverse filtration scenarios and feed solution of varying complexity. Overall, these pre-filters fall into two categories: depth-filtration-based and membrane-filtration-based virus removal pre-filters. Paired with virus removal filters, these options meet the filtration requirements of the vast majority of customers.
The combination of filters can be selected based on the specific characteristics of the biopharmaceutical solution. For most antibody applications, depth pre-filters offer superior impurity adsorption capacity, delivering enhanced protection when paired with PES virus removal filters. Conversely, in the plasma derivatives sector, cleaner membrane pre-filters are more commonly preferred; when paired with RC virus removal filters, which possess strong fouling resistance, they deliver outstanding filtration performance. Detailed material, component specifications, and protection mechanisms for the different pre-filters are summarized in the table below.
Viruclear™ PDT Virus Removal Pre-filter (Depth filter)
The Viruclear™ PDT is designed as a depth filter with outstanding adsorption performance. This allows it to effectively remove aggregates and other subvisible particulate impurities from the intermediate feed, which protects the performance of the downstream virus removal filter.
As a conventional product that was launched earlier in the portfolio, the PDT has already received approval and achieved commercialization in multiple customer biopharmaceutical projects.
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Viruclear™ PDA Virus Removal Pre-filter (Depth filter)
The newly launched Viruclear™ PDA is a depth prefilter constructed primarily from cellulose fibers and diatomaceous earth. Through the incorporation of specific charged resins, this model achieves excellent adsorption performance which results in significantly reducing Host Cell Protein (HCP) levels in the intermediate feed at the virus filtration stage. This capability makes it an ideal pre-filter option for customers who have stringent HCP reduction requirements.
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Viruclear™ PDS Virus Removal Pre-filter (Depth filter with synthetic material)
The Viruclear™ PDS virus removal pre-filter employs fully synthetic depth media with strong non-specific adsorption to remove protein aggregates and other impurities. The media are entirely synthetic, containing no natural fibers, which results in lower extractables and leachables profiles while avoiding interference from β-glucan leaching in feed stream assays.
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Viruclear™ PNY Virus Removal Pre-filter(Nylon)
The Viruclear™ PNY is a specially optimized virus removal pre-filter based on nylon membrane, with a nominal pore size of 0.1 μm. It effectively removes protein aggregates and hydrophobic impurity through a combination of size exclusion and hydrophobic adsorption. Its three-layer membrane stack design significantly enhances retention and adsorption capacity, thereby improving the filtration stability of the downstream virus removal filter.
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Viruclear™ PCE Virus Removal Pre-filter (PES)
The Viruclear™ PCE is a PES-based pre-filter with anionic modifications and features a nominal pore size of 0.2 μm. It removes aggregates and other impurities through electrostatic adsorption and size-based retention，which effectively protects the capacity of the downstream virus removal filter. Given its cation-exchange adsorption mechanism, this pre-filter is typically recommended for feed streams operating under low pH (< 6) and low conductivity (< 25 mS/cm) conditions.
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Corevital™ SMD 0.2/0.1 & Purcise™ MEC 0.2/0.1 (Size-Exclusion-Based & Sterile-Grade)
Cobetter offers two virus removal pre-filter options. The Corevital™ SMD 0.2/0.1 μm filter is equipped with a high-grade sterile hydrophilic PVDF membrane, while the Purcise™ MEC 0.2/0.1 μm filter features a sterile hydrophilic PES membrane. Both rely on share size exclusion to remove impurity and are typically recommended for use in two scenarios: in combination with RC virus removal filters, which offer superior fouling resistance, or for virus pre-filtration of low-concentration, high-purity therapeutic recombinant protein products.
Order Information for Corevital™ SMD 0.2/0.1
Order Information for Purcise™ MEC 0.2/0.1
