Ensuring that viral clearance studies achieve the needed log reduction values (LRV) or viral reduction values (VRV) for regulatory requirements is critical in avoiding delays in clinical trials or manufacturing schedules. While researchers and contract manufacturing organizations (CMOs) may be knowledgeable about their specific molecules and purification processes, they often lack comprehensive understanding of the various factors influencing virus selection for clearance studies.
The selection of specific viral strains, ideally a non-human infectious model virus, is critical to ensuring the viral challenge to the purification evaluation is representative of endogenous or introduced viral contaminants. The chosen strains must also align with regulatory guidelines based on intended filing location, product development stage, and exposure risks. Additionally, the evaluation of viral clearance should consider worst-case scenarios, including factors such as time, temperature, pH, and robust virus titers.
The critical aspects of viral clearance studies are essential for meeting regulatory standards and preventing delays in clinical trials or manufacturing. Join our webinar as we explore: