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Viral Clearance Service

As a pioneer in biosafety testing, Creative Biogene offers a wide range of virus clearance service for pharmaceuticals, biopharmaceuticals and medical devices. With years of experience, we provide accurate and reliable viral clearance services to meet different needs. All services are performed in accordance with the guideline of governing agencies.

The risk of viral contamination is a common feature to all biotechnology products derived from cell lines. Products with viral contamination may lead to serious clinical consequences. Thus, viral clearance is an essential part of quality control in manufacturing process. And the goal of viral clearance is to obtain the best reasonable assurance that the product is free of virus contamination. Process evaluation requires knowledge of how much virus may be present in the process and how much can be cleared in order to assess product safety. Every step in manufacturing process may have an indirect effect on the viral inactivation/removal achieved. The type and extent of viral tests and viral clearance studies required at different steps of production will depend on various factors and should be considered on a case-by-case and step-by-step basis.


Creative Biogene offers an evaluation and characterization service for viral clearance in manufacturing process. This service is to assess process step(s) that can be considered to be effective in inactivating/removing viruses and to estimate quantitatively the overall level of virus reduction obtained by the process. At Creative Biogene, our services are carried out in a manner that is well documented and controlled. To date, our experienced scientists have worked with a wide range of products, like monoclonal antibodies and recombinant proteins. Custom service is welcome as well.

For more information, please feel free to contact us at or 1-631-626-9181.


  1. ICH Topic Q 5 A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

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