Best practices from Vironova Biosafety in new publication
Vironova Biosafety specialize in viral clearance studies for biological drugs. These kinds of drug products based on live cells have an inherent risk for viral contamination that could cause serious harm or death to patients.
So Vironova Biosafety’s work is a critical part of a drug license holder’s application for regulatory approval in which it must demonstrate that a manufacturing process can remove or inactivate viral contaminants.
This week you can read an article entitled “Putting viral clearance capabilities to the test” on Biopharm International with contributions by Gustav Gilljam, client project manager at Vironova Biosafety. He describes the key elements to planning a virus clearance validation and the article as a whole, with contributions from several experts, gives a thorough overview of the scope and challenges of this work.
Read the article here