Sartorius Lab Instruments GmbH & Co. KG Virus Filters 5452528V1

Virus filtration with Virosart® CPV is an integral part of the orthogonal virus clearance technology platform at Sartorius Stedim Biotech. This orthogonal technology platform features virus filtration, virus inactivation and virus adsorption. Virosart® CPV shows efficient removal of both small non-enveloped viruses (20 nm) and large enveloped viruses (>50 nm) from biopharmaceutical feed stream by size exclusion. The double layer 20 nm PESU membrane of Virosart® CPV features excellent flow rates and superior capacity. The filter offers highest viral safety over the entire flow decay profile up to 90%. Virosart ® CPV filters are being tested for integrity using a water based integrity test. All filters have been validated for 4 log10 removal of small non-enveloped viruses using bacteriophage PP7 as a model virus. Each individual Virosart® CPV filter is autoclaved and integrity tested during manufacturing assuring highest product reliability. Virosart® CPV provides highest viral safety to the biopharmaceutical product. This filter retains more than 4 log10 of small nonenveloped viruses (PPV or MVM) and more than 6 log10 of large enveloped viruses (e.g. MuLV). Based on the unique double layer 20 nm PESU membrane, Virosart® CPV provides excellent flow rates and superior capacity. This filter offers highest viral safety over the entire flow decay profile of up to 90%. Scalability: Scale down work is being realised 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 being performed using this capsules size 9 with filter area of 2.000 cm2 to reliably scale up into larger scale manufacturing. Typical batch sizes of products being subject to nanofiltration with this Virosart® CPV capsule size 9 are 5 to 50 liter.