Viral Clearance Studies
Utilize our management of comprehensive viral clearance studies that will support further development of product.
With you on your biologics journey...
Why viral clearance studies?
Viral contamination is a common risk for biotechnology products derived from human and animal cell lines. Such viral contamination can arise from multiple sources and can lead to serious clinical and commercial consequences.
Therefore, it is expected by the regulatory agencies that the safety of these products with regards to viral contamination can be reasonably assured by the application of a virus testing program and an assessment of the manufacturing process to remove and inactivate those viral contaminants.
3P´s initial viral clearance studies
The first objective of viral clearance studies is to identify all manufacturing process steps that contribute to the removal or inactivation of viruses. We then select a minimum of two orthogonal process steps for further evaluation. Process steps must be completely independent, have distinct mechanisms for virus removal or inactivation, and collectively demonstrate sufficient viral clearance.
For each process step selected, we establish and validate a scale-down model. Furthermore, we choose a panel of viruses containing viral contaminants relevant to the specific product and cell line. Finally, the scaled-down models, virus panel, and process intermediates are used to perform spiking studies and assessing the capacity to remove or inactivate the viruses. Results from the spiking studies provide a quantitative estimation of the viral reduction capability for each process step.
Viral clearance studies are conducted in specialized laboratories by a third-party provider; this is a standard industry practice to avoid viral contamination risks at our production and development facilities.
What we will deliver
We provide complete management of viral clearance studies with a comprehensive final report supporting further development of the product.