Twenty plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal.

Virus filtration has been demonstrated to be an effective and robust dedicated viral clearance step that is used in biopharmaceutical manufacturing processes. Here we present virus filtration data from a multicompany collaboration with data compiled from WuXi Advanced Therapies' and Charles River Laboratories' internal viral clearance databases spanning more than 25 years. The data were sorted by virus removal and type and then further subdivided into murine leukemia virus only, pseudorabies virus only, and reovirus type 3 only categories to allow for analyses of viral clearance results.

Improving viral filtration capacity in biomanufacturing processes using aggregate binding properties of polyamide-6,6.

Virus retention filtration is a common step in modern biopharmaceutical manufacturing as it enables efficient removal of potential adventitious and endogenous viruses via size exclusion. Modern parvovirus retention filters have significantly improved fluxes and parvovirus retention in comparison to earlier versions of these filters. However, these filters may be more susceptible to premature fouling and require more effort for process optimization.

The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim.

Low pH inactivation of enveloped viruses has historically been shown to be an effective viral inactivation step in biopharmaceutical manufacturing. To date, most statistical analyses supporting modular low pH viral inactivation claims have used descriptive statistical analyses, which in many cases do not allow for probabilistic characterization of future experimental log reduction values (LRVs). Using Bayesian hierarchical logistic regression modeling, probability statements regarding the likelihood of successful low pH viral inactivation based on only certain process parameter settings can be derived.