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 the effectiveness of the virus removal step when deviating from typical process parameters. Recently, it was discovered that, for some virus removal membranes, when operating at the edge of typical process parameters, virus breakthrough is more likely. This poster summarizes the results of a robustness study with Virosart® HC, which examined various process parameters known potentially to affect virus retention.