Depth filtration is widely used in antibody manufacturing for cell removal in harvesting. During depth filtration, process related impurities including DNA, host cell protein, and virus may also be partially removed. However, removal of product related impurities by depth filtration in harvesting is rarely studied. Antibody aggregate can be formed in cell culture and may cause product efficacy issues or adverse effects in antibody therapy. Antibody aggregate is normally removed in downstream by polishing chromatography steps. This work reports the removal of antibody aggregate by depth filtration in harvesting. This new strategy for aggregate control could enhance the process robustness or further simplify the process. The formation of specific aggregate species in cell culture and the mechanism of aggregate adsorption by depth filter will be discussed for in depth product and process understanding.

Antibody aggregate removal by depth filtration in cell culture harvesting

253rd National Meeting (2017)

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