By Horst Ruppach, PhD
Volume 12, Issue 4 (Winter 2013/2014)
Viral clearance studies are required for pharmaceuticals derived from human and/or animal sources such as recombinant proteins produced in eukaryotic cell lines, human blood products and vaccines, and even for some critical class III medical devices. It is mandatory to demonstrate that steps in the manufacturing process are capable of inactivating or removing potential viral contaminants. For this, a laboratory-scale (downscale) of the process step is developed and challenged with different model virus solutions. The viral concentrations are quantitatively determined in the feed material and the relevant product fraction. The ratio of both defines the reduction in virus and specifies the viral inactivation or viral removal capacity of the investigated process step…
Citation: Ruppach H. Log10 Reduction Factors in Viral Clearance Studies. BioProcess J, 2014; 12(4): 24-30. https://dx.doi.org/10.12665/J124.Ruppach
Posted online January 7, 2014