Novel Validation Method of Virus-Removability for Biological Cell Culture Products Using Polymeric Membrane Filters

We intend to establish a new validation method to give the validatable membrane filter for purification of bio-drug manufacturing process. The method is composed of two types of testing, that is, destructive tests such as tests determining bubbling point and mean pore size for hollow fibers obtained by sampling, and a nondestructive test of the new pressure hold method for all the filters composed of hollow fibers. The removability of Japanese encephalitis virus (JEV) for the cuprammonium regenerated cellulose hollow fiber (BMM™) filter was completely validated through this method. The removability of JEV showed a close relationship to that of gold particles resulting in the new integrity testing method using gold particles by the users of this filter.