Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
AssigneeAbbVie Inc.
InventorsPatrick Hossler, Sean McDermott, Christopher Racicot, Ivan Correia
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Abstract
The present invention relates to the field of protein production, and in particular to methods and compositions for modulating glycosylation of proteins expressed in host cells.
Claims44
A method of producing a composition comprising a protein with a modulated glycosylation profile, said method comprising:
- culturing a host cell expressing said protein in cell culture media supplemented with a monosaccharide and/or an oligosaccharide, thereby producing said composition comprising said protein with a modulated glycosylation profile as compared to a control,
- wherein said control is a composition comprising a protein produced by culturing a host cell expressing said protein in cell culture media which is not supplemented with a monosaccharide and/or an oligosaccharide.
A method of producing a composition comprising an antibody, or antigen binding fragment thereof, with a modulated glycosylation profile, said method comprising:
- culturing a host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media supplemented with sucrose and/or tagatose, thereby producing said composition comprising said antibody, or antigen binding fragment thereof, with an increased level of mannosylated N-glycans and a decreased level of fucosylated N-glycans as compared to a control,
- wherein said control is a composition comprising an antibody, or antigen binding fragment thereof, produced by culturing a host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media which is not supplemented with tagatose and/or glucose.
A method of producing a composition comprising an antibody, or antigen binding fragment thereof, with a modulated glycosylation profile, said method comprising:
- culturing a host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media supplemented with sucrose and/or tagatose, thereby producing said composition comprising said antibody, or antigen binding fragment thereof, with a 1-50% increase in the level of mannosylated N-glycans and a 1-50% decrease in the level of fucosylated N-glycans as compared to a control,
- wherein said control is a composition comprising an antibody, or antigen binding fragment thereof, produced by culturing a host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media which is not supplemented with tagatose and/or glucose.
A composition comprising a cell culture media comprising a monosaccharide and/or an oligosaccharide.
A composition comprising a therapeutic protein, wherein said protein comprises a 1-50% increase in the level of mannosylated N-glycans and a 1-50% decrease in the level of fucosylated N-glycans, as compared to a control,
- wherein said control is a composition comprising a protein produced by culturing a host cell expressing said protein in cell culture media which is not supplemented with a monosaccharide and/or an oligosaccharide
A method of producing a composition comprising an antibody, or antigen binding fragment thereof, with a modulated glycosylation profile, said method comprising:
- culturing a host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media supplemented with sucrose and/or tagatose, thereby producing said composition comprising said antibody, or antigen binding fragment thereof, with a 1-30% increase in antibody-dependent cellular cytotoxicity (ADCC) response as compared to a control,
- wherein said control is a composition comprising an antibody, or antigen binding fragment thereof, produced by culturing a host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media which is not supplemented with tagatose and/or glucose.
Dependencies are inferred from the claim text.