Biotechnology Services
Process Validation for Viral Clearance |
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Blood Products
The number of viruses used to validate the purification process for blood products is related to the history of the donors and the risks posed by the product itself. Human blood products are considered to be relatively high risk, and it will usually be necessary to include four or more viruses in the validation.
There are several considerations that should be borne in mind when choosing the viruses to include in a validation: First, the process should be validated against a range of virus types with different physicochemical properties and stabilities in order to demonstrate that any contaminant which gets into the system will be cleared by the process. Second, where possible, the viruses used should be those able and likely to infect human blood. Third, the range of viruses used should include at least one that is known to be difficult to inactivate or remove.
There are also several technical considerations to resolve. Again, Covance's experience enables us to provide the expertise you need to make the best choices. |
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