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Contact Us +44 (0)141 946 9999


Contact Us


+44 (0)141 946 9999

Tel +44 (0)141 946 9999


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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

With repeated use the ability of chromatography columns and other devices used in the purification process to clear virus may vary. Therefore, it is required that the reliability of reduction of virus with multiple column uses should be evaluated. We perform column resin sanitization and columns re-use studies to determine the potential for carry-over of virus and microbial agents during multiple cycles of chromatography resins. Additionally, we have extensive in-house data on the inactivation of a panel of viruses using different concentrations of the common cleaning reagent, sodium hydroxide.

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