Viral Clearance Studies

Investigations of the ability of a biopharmaceutical product’s manufacturing process to remove or inactivate viral agents can provide assurance of the virus safety of the product, as detailed in international guidelines. Such studies are essential prior to any clinical trials. ViruSure offers GLP as well as non-GLP viral clearance studies including consultancy on the best study design. We base the study design on the vast expertise of our scientists acquired over decades performing virus clearance studies.

We have performed the virus clearance studies across a wide range of biopharmaceutical products. Whether your product is early stage or in late-phase clinical trial, we ensure the best study design to meet regulatory requirements.

At the process level, the study design must also include orthogonal process steps. These are defined as process steps with different mechanisms of virus inactivation or removal.

Selection of the virus panel is a critical element of your viral clearance study and is dependent on the risk profile of the product. The selection should cover a range of viruses with different physicochemical properties, including those with high resistance to inactivation, and viruses which are potential contaminants.