Zeta Plus™ VR Series Filters For Viral Reduction In Biopharmaceutical Processes

The removal and/or inactivation to a high level of assurance of contaminating viruses from biotherapeutics is a requisite for ensuring product safety. Many biotherapeutic products are produced using mammalian cell culture techniques. Contaminating viruses can enter cell culture systems from a number of sources including animal derived nutrient additives, the cell line itself, or through adventitious contamination via human or animal process contact. Screening methods to detect viral contamination are not adequate to ensure product safety due to limitations in assay sensitivity. For this reason process engineers must design into processes viral clearance steps to address adventitious contamination events. Regulatory requirements state that at least two viral clearance steps operating by different mechanisms should be employed in processes.

This Application Brief presents:

• The use of CUNO Zeta Plus™ VR Series filters to provide viral clearance of animal derived growth media feedstreams and of downstream process purification steps such as eluate from chromatography columns.
• The principal mechanism of viral clearance operative with Zeta Plus VR Series filters is electrokinetic adsorption. Because Zeta Plus VR Series filters function in an ion-exchange like manner, they complement viral clearance steps such as inactivation and size exclusion filtration.
• Zeta Plus VR Series filters offer an effective means of prefiltration to membrane based viral retentive filters.

Industry experience with Zeta Plus VR Series filters has resulted in effective removal of enveloped and non-enveloped viruses from blood and plasma as well as aqueous buffer systems. The typical log reduction value (LRV) exhibited by Zeta Plus VR Series filters is 2 to 6 logs.