The PES based virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in biopharmaceutical applications. Virosart® CPV is the optimal virus filter for monoclonal antibodies or small recombinant proteins.
Virus filtration with Virosart® is an integral part of the orthogonal virus clearance technology platform of Sartorius Stedim Biotech. This orthogonal technology platform features virus filtration, virus inactivation and virus adsorption. The Virosart® product range includes three different virus retentive membranes, in order to provide the best solution for every application.
Virosart® CPV is the optimal virus filter for monoclonal antibodies (Mab), antibody fragments (Fab) or small recombinant proteins (>150kDa). Virosart® CPV is used at the end of the purification process for virus retentive filtration of the biopharmaceutical product. At this stage the purity of the biopharmaceutical product is the highest and virus filter blockage due to contaminants (DNA, CHOP, aggregates & lipoproteins) is the lowest.
Virosart® CPV provides highest virus safety of the biopharmaceutical product. The filter retains more than 4 log10 of small non-enveloped viruses (e.g. PPV, MVM) and more than 6 log10 of large enveloped viruses (e.g. MuLV). Based on the unique double layer 20 nm PES membrane, Virosart® CPV provides excellent flow rates and superior capacity. This filter offers highest virus safety over the entire flow decay profile. The performance of the final virus filter mainly depends on the feed stream properties. Therefore, appropriate feed stream conditioning i.e. through efficient pre-filtration is a major aspect with the development of a virus filtration step.
Scale down work is realized using the Virosart® CPV Minisart (5 cm2 capsule) to enable filtration work for flow and capacity studies as well as for GLP virus spiking studies. Scale up studies are performed using Virosart® CPV capsule and|or MidiCaps® (180 cm2 | 2.000 cm2) to reliably scale up into larger scale manufacturing. Large scale manufacturing is operated with Virosart® CPV MaxiCaps® or cartridges.
Virosart® CPV filters are tested for integrity using a water based integrity test with the Sartocheck® technology of Sartorius Stedim Biotech. Virosart® CPV filters have been validated for 4 log10 removal of small non-enveloped viruses using bacteriophage PP7 as the model virus. Validation data is shown in the validation guide of Virosart® CPV. Each individual Virosart® CPV filter is autoclaved and integrity tested during manufacture assuring highest product reliability. Virosart® CPV filters are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.