Viral Clearance Solutions
A range of filters and filter capsules optimized to provide robust, economic solutions for virus removal whatever your process requirements. Available in small-scale formats for rapid process development that scale to large format filters and filter capsules for clinical manufacture Pall virus filters deliver the performance you need at all scales.
Pall Pegasus Prime virus membrane provides robust virus retention to protect critical manufacturing bioprocesses, assure drug quality and safeguard health. These gamma irradiated filters combine high flow and robust capacity, to simplify your process and deliver sustainable economy at all scales.
Pall's Pegasus SV4 virus filters combine constant, stable flow-rates with high viral clearance to significantly reduce processing costs and enable maximum filtration economy in medium to high fouling process fluids.
Specialist Virus Filtration
Pegasus Prime Virus Filtration
Viral Clearance and Viral Safety
The Prime Choice
The risk of viral contamination is a feature of all biotechnology products derived from cell lines or other biological sources. The safety of these products can only be reasonably assured by ensuring the absence of contaminating viruses from media components and other raw materials as well as by implementing a robust virus removal or inactivation and testing program in the manufacturing process. The confidence in the absence of virus contamination in the product in most instances is derived mainly from the ability to demonstrate the virus clearance ability of the manufacturing process rather than the testing of the product. This in addition to addressing risk associated with known viruses, also “provides a measure of confidence that any unknown unsuspected harmful viruses may have been removed”. Thus the evaluation and characterization of virus removal procedures occupy a central position in the overall risk mitigation strategy.
Virus filtration using specifically designed virus removal filters is an established and effective means of removing potentially hazardous virus particles from pharmaceutical articles.
Pegasus Prime Virus Removal Filters are designed for highly efficient clearance of large and small enveloped and non-enveloped viruses, from biological solutions. They combine robust, high viral clearance with high flow rate for biological fluids providing an economical solution. The validation data have demonstrated robust > 4 log titer reduction for ~ 25 nm PP7 bacteriophage which is a model for parvovirus, as recommended in PDA Technical Report 413.
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