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US 12,747,289 B2Granted
Manufacturing methods for producing anti-IL12/IL23 antibody compositions
AssigneeJanssen Biotech, Inc.
InventorsKristopher Barnthouse, Subinay Ganguly, Maarten Groeneveld, Manuel Lopez, Jr., Michael Nedved, Kevin D. Smith
Life of this patent
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Abstract
Methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody ustekinumab, in CHO and specific pharmaceutical compositions of the antibody are useful in treating various diseases.
Claims4
A method of manufacture for producing an anti-IL-12/IL-23p40 antibody comprising amino acid sequences selected from the group consisting of:
- (i) a heavy chain (HC) comprising the amino acid sequence of SEQ ID NO:10 and a light chain (LC) comprising the amino acid sequence of SEQ ID NO:11;
- (ii) a heavy chain variable domain amino acid sequence of SEQ ID NO:7 and a light chain variable domain amino acid sequence of SEQ ID NO:8;
- and (iii) heavy chain CDR amino acid sequences of SEQ ID NO:1, SEQ ID NO:2, and SEQ ID NO:3, and light chain CDR amino acid sequences of SEQ ID NO:4, SEQ ID NO:5, and SEQ ID NO:6, wherein the anti-IL-12/IL-23p40 antibody is produced by the steps of:
- a. culturing a Chinese Hamster Ovary cell (CHO cell) with nucleotides encoding the anti-IL-12/IL-23p40 antibody;
- b. expressing the anti-IL-12/IL-23p40 antibody in the CHO cell;
- c. purifying the anti-IL-12/IL-23p40 antibody;
- and
- d. determining that the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody comprises total neutral oligosaccharide species>99.0%, total charged oligosaccharide species<1.0%, and individual neutral oligosaccharide species G0F>70.0%, G1F<20.0%, and G2F<5.0%.
5 more elements
Dependencies are inferred from the claim text.