Viral Clearance

Choose our Viral Clearance Study Services to demonstrate viral clearance capacity while demonstrating scalability equivalence from bench to manufacturing scale and vice versa.

Our expertise in viral clearance studies provides documentation for both the removal of viruses associated with your product and the estimation of the process’s robustness in removing potential adventitious viruses.

The risk of viral contamination is a feature common to all biotechnology products derived from cell lines. The contamination may arise from the original source of the cell lines or from the introduction of adventitious viruses during the production process. Nevertheless, the safety of your product is expected to be assured via the introduction of viral removal testing and inactivation programs, which are submitted in the product registration package.

We perform viral clearance studies to document the removal of viruses known to be associated with your product and to estimate the robustness of the process to remove potential adventitious viral. The viral inactivation study typically involves the testing of viruses in various process steps.

According to industry standards, virus clearance and inactivation are executed using a scaled-down developed process model at an independent contract laboratory. Evaluating viral clearance strategies requires demonstrating the equivalence of scalability from bench to manufacturing scale and vice versa.

Once the manufacturing process has been evaluated and the potential viral clearance steps identified, spiking studies are carried out.

Rely on us to deliver the complete management of viral clearance studies and provide a comprehensive final report to support further product development.