Viral Clearance Studies and Validation
Discover how our management of comprehensive viral clearance studies and validation is conducted in specialized laboratories by third-party providers to match your project's priorities in terms of timelines and risk.
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 viral clearance studies and validation
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.
When assembled for viral clearance validation studies, the virus panel includes a more extensive range of virus types than during initial viral clearance evaluation, providing us with a better understanding of the viral clearance capabilities while also demonstrating process robustness. Using the augmented virus panel and scale-down models, we perform process intermediate spiking studies which assess the capacity of each process step to remove or inactivate the viruses.
Results from the spiking studies provide a quantitative estimate of the viral reduction capability of 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 support and overall management of viral clearance studies and validation, with a comprehensive final validation report.