Robustness Study for Virus Retentive Filtration of Plasma Derivatives
Plasma products have traditionally been derived from human plasma, for which current regulatory guidelines require at least two orthogonal steps for inactivation and|or removal of viruses.
One method is virus filtration, using virus removal membranes. In addition to demonstrating virus removal through spiking studies, the industry tends to conduct additional robustness studies to prove to authorities the effectiveness of the virus removal step when deviating from typical process parameters. Recently, however, it was discovered that when deviating from typical process parameters, with some virus removal membranes, virus breakthrough is more likely. This poster summarizes the results of a robustness study with Virosart® HC, which examined various process parameters known to potentially affect virus retention.