Virus Filtration Under Challenging Conditions

As a part of the downstream virus clearance requirement, multiple orthogonal unit operations should be evaluated.

In contemporary virus clearance submissions, it is common to evaluate a capture column (Protein A), a polishing column (AEX, CEX, or HIC), low pH inactivation, and Virus Retentive Filtration (VRF). Since VRF is considered to function from a defined size-exclusion based principle, VRF has been thought to perform independently from the physicochemical properties of virus, making VRF a robust tool for virus removal for viruses greater than 20 nm.