Viral Clearance Assays and Services

Viral Clearance

Viral clearance studies are designed to assess the effectiveness of individual steps in a manufacturing process to reduce (removing or inactivating) potential contaminant viruses. The data is used from a study to provide a quantitative estimate of the overall level of virus clearance obtained during the manufacturing process. For viral clearance studies, infectivity assays are the preferred method to determine the effectiveness of a process step in removing and/or inactivating infectious agents. Valuable additional data on the partitioning of viruses can be obtained by the use of a quantitative polymerase chain reaction (Q-PCR) assay.

Column Re-use Studies