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There is an increasing requirement from regulatory
authorities to study the ability of column resins that are re-used
to clear viruses after multiple runs. At BioReliance, we regularly
perform column re-use studies to satisfy this regulatory request.
We have performed cleaning studies (laboratory
cleandown procedures, and equipment sanitization) and a number of
studies looking at carry over of viruses during column chromatography
steps. In addition, we have extensive in-house data on the inactivation
of a panel of viruses using different concentrations of sodium hydroxide.
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