Zeta Plus™ VR Series Filters For Viral Reduction In Blood Plasma Fractionation Processes

The removal and/or inactivation to a high level of assurance of contaminating viruses from blood derived therapeutics is a requisite for ensuring product safety. 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 Applications Brief presents:

• The use of 3M Purification Zeta Plus VR Series filters to provide viral clearance from blood fractionation processes.
• 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.
• 3M Purification 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 plasma and aqueous buffer systems. The typical log removal value (LRV) exhibited by Zeta Plus VR Series filters is 2 to 6 logs.