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Design And Performance Of Viral Clearance Studies
December 3, 2010
•Article: Design And Performance Of Viral Clearance Studies
By Katherine Bergmann and Barry Rosenblatt
The risk of virus contamination is a feature common to all biotechnology products. Contamination can arise from a source cell line or from adventitious virus introduced during production. Three complementary approaches are used to assure the viral safety of a biotechnology product. First, source cell lines and raw materials are tested for freedom from viruses. Second, in-process testing programs assess the presence of viruses in the crude product and assure freedom from those viruses in the final product.
The third component is the assessment of viral clearance during purification. Viral clearance measures the capacity of a purification process to remove and/or inactivate viruses. Such studies involve deliberately spiking viruses into process intermediates and demonstrating their inactivation or removal during subsequent processing steps. Expectations for design and performance of these studies are detailed in various regulatory documents (listed in the "Regulatory Guidance" box).
Reprinted with permission from BioProcess International 4(10):65-64 (November 2006)
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