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Post-Viral Inactivation Filtration for Impurity Removal in Biopharmaceutical Processes

Jeffrey E. Galvin, David Maheu, and Sushil Abraham. Process Development, Amgen, 4000 Nelson Road, Longmont, CO 80503

Viral inactivation is a critical bioprocessing step that employs chemical treatments such as pH titration or addition of surfactants to inactivate enveloped viral contaminants. A filtration step often follows the viral inactivation to reduce the turbidity that results from the chemical treatment. This paper describes the development and characterization of a post-viral inactivation filtration step for a biopharmaceutical process. In addition to reducing turbidity, the filtration step also removes impurities such as host cell proteins and nucleic acids. Although the purification process already shows sufficient capability to remove these impurities, the post-viral inactivation filtration significantly reduces the burden on downstream steps, thereby increasing overall process robustness and consistency.