Virus filtration is a size-exclusion-based technology that uses specialized membrane filters with defined pore sizes (typically ranging from 20 to 40 nanometers) to physically remove virus particles. Virus filtration is a critical step in the biopharmaceutical development and manufacturing processes, aiming to effectively remove viruses and ensure the safety of biological products such as recombinant proteins, antibodies, blood-derived products, and vaccines.
Amerigo Scientific provides Valpha® virus removal filters for efficiently removing virus particles from biological products such as plasma products, antibodies, and proteins. These filters are validated to provide reliable virus retention even at high levels of virus challenge.
The key performance parameters of filtration usually include logarithmic removal rate (LRV), flux, and load, which are influenced by interacting factors such as viral load, protein concentration, impurity concentration, pressure, process flow rate, ionic strength, and process interruptions. Therefore, it is very important to select and verify the appropriate virus removal filter under the given process conditions. Valpha® virus removal filters use innovative high-performance polymer membranes to trap the virus on the membrane surface and in the membrane pores. Two Valpha® filter membranes are available, namely Valpha® Regenerated Cellulose (RC) and Valpha® Modified Polyethersulfone (PES).
Valpha® PES membrane is a modified polyethersulfone material. Its unique asymmetric structure provides more possibilities for achieving high flux. The unique modification and membrane preparation process enable Valpha® PES membrane to have a very low protein adsorption rate and a high flow rate, achieving the filtration characteristics of high flux, high load and high retention rate.
The cellulose used in Valpha® RC is a highly hydrophilic material. The natural hydrophilic property of cellulose can reduce protein adsorption, thereby maximizing protein recovery rate. In addition, the cellulose membrane can maintain high LRV and filtration flow rate during long-term filtration. Valpha® RC has wide applicability and is suitable for virus removal process of multiple biological products.
| Valpha® PES | Valpha® RC | Valpha® RC HP |
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| Product | Product Characteristics |
|---|---|
| Valpha® Syringe Filter | Effective membrane area of 2.8cm², suitable for process development scale |
| Valpha® Capsule Filter | 2.5"/5"/10" filter suitable for pilot scale; 20"/30" filter suitable for production scale |
| Valpha® Cartridge Filter | 2.5"/5"/10" filter suitable for pilot scale; 20"/30" filter suitable for production scale |
| Membrane Material | Valpha® PES | Valpha® RC | Valpha® RC HP | |||||||||||||
| Specification (inch) | 1 | 2.5 | 5 | 10 | 20 | 30 | 2.5 | 5 | 10 | 20 | 30 | 2.5 | 5 | 10 | 20 | 30 |
| Effective filtration area (m²) | 0.04 | 0.125 | 0.25 | 0.5 | 1 | 1.5 | 0.16 | 0.4 | 0.8 | 1.6 | 2.4 | 0.16 | 0.4 | 0.8 | 1.6 | 2.4 |
| Component form | Capsule | Capsule; Cartridge | ||||||||||||||
| Connection | TC connector at both ends (Capsule)；226 (Cartridge) | |||||||||||||||
| Material | PP (Polypropylene) | |||||||||||||||
| ISO®9001 quality standard | The R&D, production and delivery process of the products follows the requirements of quality management system of ISO9001:2015 | |||||||||||||||
| Membrane PP7 retention testing | Valpha® membrane - Phage PP7 retention test result indicates that at the challenge level of 10⁷ pfu/cm², LRV> 4.0 | |||||||||||||||
| Device PP7 retention testing | Valpha® filter - Phage PP7 retention test result indicates that at the challenge level of 10⁷ pfu/cm², LRV> 4.0 | |||||||||||||||
| Fiber releasing | In compliance with the none fiber release standard of 21CFR 21.3 (b)(6) | |||||||||||||||
| USP <87> cytotoxicity test | The components of Valpha® filter have been tested to meet the standards of class Ⅵ plastics (according to USP <87> cytotoxicity test) | |||||||||||||||
| USP <88> biological reactivity | The components of Valpha® filter have been tested to meet the standards of class Ⅵ plastics (according to USP <88> biological reactivity test) | |||||||||||||||
| Sterilization method | Gamma resistance | Autoclavable (Capsule); SIP (Cartridge) | ||||||||||||||
| Maximum operation pressure | Forward: 4.1bar (60psi) at 4~30°C | |||||||||||||||
| Bacterial endotoxin | The water extract was tested for endotoxin and the endotoxin content was less than 0.25 EU/ml | |||||||||||||||
Experimental scheme:
Figure 4. Performance Comparison of Valpha® RC with Supplier#A PVDF
Figure 5. Performance Comparison of Valpha® PES with Supplier#B/C PES
Vshell® pre-filter is designed to work together with Valpha® virus retention filter to provide a reliable virus safety guarantee for the virus filtration process. A variety of specifications of pre-filters are available to meet different process requirements, achieving effective and robust virus removal results.
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