In vitro Testing for Adventitious Viruses in Three Cell Lines:

Protocol # CB109, Turnaround time:  3-4 weeks

The purpose of this study is to determine if there are adventitious viruses in the test material capable of growth in one or more of the cell lines used in a cell culture system.  The cell lines are selected by study sponsor based on the source of the biological product.  The test material is inoculated onto three different cell types in duplicates, incubated for 14 days during which routine cell culture maintenance is performed and any unusual changes recorded (for example the observation of cytopathic effects is recorded).  At the same time, positive and negative control wells are included in each of the three cell lines and are observed during the fourteen day incubation period.  At the conclusion of the study, hemadsorption and hemagglutination assays are performed using red blood cells from three different species at three different temperatures.  Observations are recorded and the data is described in detail in a final report that the client receives.  The studies are conducted under GLP conditions and in compliance with FDA regulations for testing biologicals.

The sponsor will be required to review and approve a protocol prior to study initiation.  Please fill out the sample submission form below in either Word or PDF format and send along with the samples.

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