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Virus removal is necessary to reduce virus level in downstream processes of biopharmaceutical manufacturing. According to relevant regulations and guidelines, the design and implementation of virus clearance research in the same production process require different virus inactivation or removal methods to ensure that biological products do not carry any potential risk of virus contamination.
Common virus removal strategies:
- Virus inactivation
- Chromatography
- Membrane filtration
In the downstream process of monoclonal antibody (mAb) production, there is often a potential risk of viral contamination. Virus removal filtration, as the most robust virus removal process, has been widely used in downstream purification processes of blood products such as coagulation factors, immunoglobulins, and recombinant proteins, antibody based biological products.
Choose the right Viruclear™ VF Filters
| Model | Key Features & Positioning |
| Viruclear™ VF | Basic Model: Cobetter first PES virus filter, establishing the technical route of 20 nm pore size, hydrophilically modified PES membrane with high flow characteristics. It is well suited for monoclonal antibodies and derivatives, making it one of the flagship models. |
| Viruclear™ VF Plus | Balanced Choice: Support-type PES membrane with optimized structural strength, balancing high flow and throughput to meet standard filtration needs for most antibody products. When used with a pre-filter, it maintains stable process flux and is also one of the flagship models. |
| Viruclear™ VF Plus X | High-Challenge Solution: Enhanced fouling resistance. Suitable for feedstreams with higher protein concentrations, greater aggregate content, or more complex compositions. |
Choose the right Viruclear™ RC Filters
| Model | Core Membrane Process and Features | Main Applications |
| Viruclear™ RC | Standard RC membrane process with excellent hydrophilicity and low adsorption. | Suitable for relatively low-concentration blood products, such as:
|
| Viruclear™ RCH | High-Throughput RC Membrane Process, Optimized for High-Concentration Feedstreams | Designed for high-concentration blood products, capable of handling immunoglobulin products at 4%–6% concentration (e.g., IV human immunoglobulin, specific immunoglobulins, etc.) |
Choose the right Viruclear™ PNY Pre-filters
| Model | Core Filtration Media | Primary Removal Mechanism | Key Features & Positioning |
| Viruclear™ PNY | 0.1 μm Nylon Membrane | Primarily size-exclusion, with additional hydrophobic adsorption | Universal and Robust Choice. Provides precise retention, serving as a reliable standard solution to protect virus filters, suitable for most well-clarified feedstreams. |
| Viruclear™ PDT | Cellulose Fibers, Diatomaceous Earth | Size-exclusion + Positive Charge + Hydrophobic Adsorption | Recommended for Many Applications. Composite media effectively removes aggregates and some HCPs, boosting virus filter throughput. |
| Viruclear™ PCE | 0.2 μm hydrophilic PES membrane， Cation Exchange Groups |
Size-exclusion+ Cation Exchange | Charge-Modified. Specifically removes negatively charged impurities (e.g., DNA, endotoxins) via ion exchange, serving as a targeted solution for charge-related contamination. |
| Viruclear™ PDS | Fully Synthetic Fibers, Silicon Dioxide | Size-exclusion + Positive charge + hydrophobic Adsorption | Excellent Adsorption and Compatibility. Made from fully synthetic materials, offering strong adsorption like PDT and meeting strict non-animal/plant origin requirements. |
| Corevital SMD 0.2/0.1 μm | 0.2+0.1 μm PVDF membrane |
Size-exclusion | Primarily used with RC virus filters for blood product filtration, removing large particulates from the solution. |
