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® HF targets the removal of both small non-enveloped viruses (20 nm) e.g. PPV, MVM and larger enveloped viruses (> 50 nm) e.g. MuLV from biopharmaceutical feed streams. Ease of use is given by sterile delivery and standard diffusion integrity testing.
The main applications for Virosart® HF for virus retentive filtration are monoclonal antibodies (Mab), antibody fragments (Fab) or small recombinant proteins (<150 kD). Virosart® HF is used at the end of the purification process for virus 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. Even if these contaminants should be removed during polishing process of the target molecule, small amounts might be sufficient to cause premature blockage of the final virus filter. To prevent this, an efficient pre-filtration step, such as the Virosart® Max, might be required as protection for the Virosart® HF membrane. The optimum pre-filter – final filter ratio has to be identified during development of the process step.
Virosart® HF provides highest virus safety to the biopharmaceutical product. Based on a unique modified PES membrane, Virosart® HF provides highest flow rates and superior capacity. The high packing density of the elements combines extremely low hold up and flushing volumes with low footprint requirements. The sterile delivery secures ease of use as well as fast installation of the filter elements. This 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). This filter offers highest virus safety over the entire flow decay profile independently of operating pressure.
The hollow fiber format supplies highest consistency and scalability from lab to process scale. Scale-down work is realized using the Virosart® HF Lab Modules (1.7 cm2 | 5.0 cm2) to enable filtration work for flow and capacity studies as well as optimizing the final pre-filter final filter ratio. These elements IT tested before delivery are also used for reliable scale-down work within GLP virus spiking studies.
Scale-up studies as well as small scale production are performed using Virosart® HF mid-scale modules (200 cm2 | 0.2 m2) to scale-up into larger scale manufacturing. Large scale manufacturing is operated with Virosart® HF process modules.
Virosart® HF filters are tested for integrity using a water-based integrity test e.g. based on the Sartocheck® technology of Sartorius Stedim Biotech. Virosart® HF 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® HF. Each individual Virosart® HF filter module is tested for integrity and water flux during manufacture assuring highest product reliability. The Virosart® HF filter modules are delivered gamma sterilized.
Virosart® HF 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.