Manufacturing methods for producing anti-tnf antibody compositions
AssigneeJanssen Biotech, Inc.
InventorsAnn Donlon, Charles Goochee, Gary Gordon, Ronan Hayes, Robin Johnston, Willem Steenvoorden, Denis Twomey
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Abstract
The present invention relates to methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNF antibody golimumab, and specific pharmaceutical compositions of the antibody.
Claims14
An anti-TNF antibody comprising an oligosaccharide profile, wherein the oligosaccharide profile of the anti-TNF antibody comprises total neutral oligosaccharide species ≥82.0% to ≤94.4%, total charged oligosaccharide species ≥5.6% to ≤18.0%, and individual neutral oligosaccharide species G0F≥25.6% to ≤42.2%, G1F≥31.2% to ≤43.6%, and G2F≥5.6% to ≤14.2%, and wherein the anti-TNF antibody is produced by a method of manufacture that controls the oligosaccharide profile of the anti-TNF antibody, the method of manufacture comprising:
- culturing eukaryotic cells in chemically defined medium controlled to contain specified trace metal concentrations of manganese and copper consisting of, Mn2+ (manganese)≥10.0 μg/liter to ≤35.0 μg/liter and Cu2+ (copper)≥1.0 μg/liter to ≤1.8 μg/liter;
- and expressing the anti-TNF antibody in the eukaryotic cells, wherein the concentrations of manganese and copper are effective at controlling the oligosaccharide profile of the anti-TNF antibody.
A method of manufacture for producing a drug substance (DS) or drug product (DP) comprising an oligosaccharide profile, wherein the oligosaccharide profile of the anti-TNF antibody is controlled and the oligosaccharide profile of the anti-TNF antibody comprises total neutral oligosaccharide species ≥82.0% to ≤94.4%, total charged oligosaccharide species ≥5.6% to ≤18.0%, and individual neutral oligosaccharide species GOF≥25.6% to ≤42.2%, GIF≥31.2% to ≤43.6%, and G2F≥5.6% to ≤14.2%, and wherein the anti-TNF antibody is produced by a method of manufacture comprising:
- culturing eukaryotic cells in chemically defined medium controlled to contain specified trace metal concentrations of manganese and copper consisting of, Mn2+ (manganese)≥10.0 μg/liter to ≤35.0 μg/liter and Cu2+ (copper)≥1.0 μg/liter to ≤1.8 μg/liter;
- and expressing the anti-TNF antibody in the eukaryotic cells, wherein the concentrations of manganese and copper are effective at controlling the oligosaccharide profile of the anti-TNF antibody.
A composition comprising anti-TNF antibodies comprising an oligosaccharide profile, wherein the oligosaccharide profile of the anti-TNF antibodies is controlled and the oligosaccharide profile of the anti-TNF antibodies comprises total neutral oligosaccharide species ≥82.0% to ≤94.4%, total charged oligosaccharide species ≥5.6% to ≤18.0%, and individual neutral oligosaccharide species G0F≥25.6% to ≤42.2%, GIF≥31.2% to ≤43.6%, and G2F≥5.6% to ≤14.2%, and wherein the anti-TNF antibodies are produced by a method of manufacture comprising:
- culturing eukaryotic cells in chemically defined medium controlled to contain specified trace metal concentrations of manganese and copper consisting of, Mn2+ (manganese)≥10.0 μg/liter to ≤35.0 μg/liter and Cu2+ (copper)≥1.0 μg/liter to ≤1.8 μg/liter;
- and expressing the anti-TNF antibodies in the eukaryotic cells, wherein the concentrations of manganese and copper are effective at controlling the oligosaccharide profile of the anti-TNF antibodies.
Dependencies are inferred from the claim text.