Several bioprocess steps contribute to viral clearance
To asses viral safety when validating a biomanufacturing process, you should study any step you claim to be reducing virus load. This assessment is usually done through a viral clearance study.
The results of the study are used as indirect evidence that the process can inactivate or remove viral contamination. Two types of biomanufacturing steps can provide viral reduction (Fig 1):
- Steps dedicated to virus inactivation or removal, such as pH treatment and heat treatment
- Steps contributing to viral clearance, such as chromatography steps dedicated to purifying the product, but with a potential to provide viral reduction
This article provides the basics of what you need to know when studying virus reduction of a chromatography step.