Virus filtration uses a membrane barrier to retain virus particles. It is a size-based removal method which uses a specifically designed polymeric membrane to retain virus particles on the surface and within the pores of the membrane. The critical performance parameters are typically the log reduction value (LRV) and the throughput. These parameters may be affected by many interacting factors such as viral load, protein concentration, presence of foulants, pressure, operating flux, ionic strength and stop start interruptions. Selecting and validating a filter for viruses appropriate for the expected range of conditions, is therefore, very important.
Pall Biotech has developed simple to use and robust products for different challenges. For the requirements of plasma processing, Pegasus™ SV4 and Ultipor® VF Grade DV20 filter have the best fit with the typical process design space; whereas for the demands of mAb processing, Pegasus Prime filters in combination with Pegasus Protect filters provide the best solution over a wide range of conditions. Both options are available in either cartridge format for integration into traditional stainless-steel processing lines, or capsule format, which may be integrated with pre-sterilized single-use manifolds.
Virus Filtration for mAb Processes
Pegasus Prime filters are unique virus removal filters which combine high flow and robust capacity. These filters can simplify process development and manufacturing processes around virus safety, and will deliver sustainable economy at all scales of mAb manufacturing.
Join the other pharmaceutical companies already using GMP scale Pegasus Prime devices.
“Pegasus Prime filter membrane was launched in 2016. In 2017, 5 pharmaceutical companies were using GMP scale Pegasus Prime devices (0.1m2 or larger). By December 2018, this more than tripled to 16 companies, of which Probiogen, BiosanaPharma, Mycenax and Roche have granted their permission to be named. Since launch, over 50 virus validation study results have been fed back to Pall, all with > 6 LRV for mammalian virus when spiked at > 6 logs.”
- Aernout Martens, Global Product Manager Virus Filtration at Pall Biotech
Advice and support for validating Pegasus Prime virus filters
Pall Biotech validation and virus filtration specialists can provide support and advice from process development through to commercialization, for the lifetime of your drug product. Key questions are:
What virus spike should I use?
The basis for successful spike selection is:
- Use the purest spike available (ultracentrifugation essential)
- Use the most sensitive assay technique (large volume assays)
- Spike only what is needed to measure your target log reduction value (LRV)
To learn more download the full guide here:
How do I incorporate a prefilter in my virus clearance study?
One of the key complications for validation of virus filters is the use of an adsorptive prefilter which cannot be validated as part of a robust size-removal virus filtration step. The decision tree in this application note will guide you to the most appropriate test method. Download here:
Virus Filtration in Continuous Bioprocessing
Continuous bioprocessing is rapidly gaining momentum in mAb bioprocessing, providing potential advantages such as smaller facility footprints, lower investment costs, flexibility and process economy. It is important to note that continuous downstream processing relies on the same fundamental concepts as batch processing. When viral filters are used in a continuous processing, operating conditions are likely to be quite different to batch mode, with much lower flow, and longer processing times in continuous processing compared to batch.
Watch the below webinar to understand the quality by design (QbD) space for the application of viral filtration in continuous bioprocessing, learn about the assessment of the critical processing parameters between batch and continuous processing, and listen to a discussion on the possible validation approach for implementation of viral filtration in continuous bioprocessing.
Virus Filtration for Plasma Processes
Pegasus SV4 virus removal filters combine high viral clearance and process cost control. They demonstrate highly-efficient clearance of both small "non-enveloped" and large viruses, and offer high retention robustness to pressure interruption (also described as pressure release, or start/stop).
The Pegasus SV4 filter membrane ensures a constant and stable flow rate when used with either dilute or complex/concentrated biological fluids, which significantly improves viral filtration economy in plasma fractionation processing.