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Article: Validation Of Adventitious Virus Removal By Virus Filtration
By Yaling Wu, Amal Ahmed, Ruta Waghmare, Paul Genest, Sylvia Issacson, Mani Krishnan, and David W. Kahn
Regulatory bodies around the world expect downstream purification processes to demonstrate robust clearance of model adventitious viruses in time for execution of phase 3 clinical trials and product licensure (1,2,3). Model viruses selected for these studies should represent a diversity of viral physicochemical properties, and the clearance methods applied should include orthogonal mechanisms such as clearance based on size alongside chemical inactivation. Virus filtration is a critical unit operation used in numerous purification processes of monoclonal antibodies (MAbs), recombinant proteins, and plasma-derived biopharmaceuticals.
Reprinted with permission from BioProcess International
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