Modulation of afucosylated species in a monoclonal antibody composition
OwnerMarc SANTORO, Kevin John JOSE +2inventors
InventorsMarc SANTORO, Kevin John JOSE, Sri MADABHUSHI, Scott GANGLOFF
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Abstract
Alterations in bioreactor cell culture feeding to an extended or continuous feed following an initial period of no feeding reduces the level of high molecular weight, acid charge, and fragment species of monoclonal antibodies expressed in the culture, and enhances the level of afucosylated species of monoclonal antibodies expressed in the culture. Regular fucose infusions following an initial period of no feed media infusion reduces the level of afucosylated species of monoclonal antibodies expressed in the culture. Cell culture manipulation may be used to modulate the level of species of monoclonal antibodies.
Claims42
A method for reducing afucosylated species of a monoclonal antibody recombinantly expressed in a bioreactor, comprising
- culturing recombinant cells that express the monoclonal antibody in a bioreactor, and
- beginning on the first, second, third, fourth, or fifth day of the culture, and continuing every day until the conclusion of the culture, infusing the culture with from about 0.5 g/L to about 5 g/L of fucose such that afucosylated species of the monoclonal antibody expressed by the cells are reduced.
A method for reducing afucosylated species of a monoclonal antibody recombinantly expressed in a bioreactor, comprising culturing recombinant cells that express the monoclonal antibody in a bioreactor, beginning on the first, second, third, or fourth day of the culture, and continuing every other day until the conclusion of the culture, infusing the culture with from about 0.5 g/L to about 5 g/L of fucose such that afucosylated species of the monoclonal antibody expressed by the cells are reduced.
Dependencies are inferred from the claim text.