# US 12,180,271 B2 · Manufacturing methods for producing anti-TNF antibody compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,180,271 B2 - Document ID: US12180271B2 - Status: Granted - Kind: B2 - Application number: 17/438,702 - Filed: 2020-02-26 - Published: 2022-05-19 - Granted: 2024-12-31 - Earliest claimed: 2019-03-14 - Assignees: Janssen Biotech, Inc. - Applicants: Janssen Biotech, Inc. - Inventors: Kristopher Barnthouse; Subinay Ganguly; Maarten Groeneveld; Manuel Lopez, Jr.; Michael Nedved; Kevin D. Smith - Web page: https://patentgrep.com/patent/US12180271B2 ## CPC - C07K 16/241: {Tumor Necrosis Factors} - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61K 2039/505: {comprising antibodies} - C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature - C07K 2317/21: from primates, e.g. man - C07K 2317/41: Glycosylation, sialylation, or fucosylation - C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC] - C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The present invention relates to methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNF antibody a recombinant anti-TNF antibody having a heavy chain (HC) comprising amino acid sequence SEQ ID NO:36 and a light chain (LC) comprising amino acid sequence SEQ ID NO:37 and compositions comprising the recombinant anti-TNF antibody. ## Claims ### Claim 1 Anti-TNF antibodies comprising: (i) a heavy chain comprising the amino acid sequence of SEQ ID NO:36; and (ii) a light chain comprising the amino acid sequence of SEQ ID NO:37, wherein the oligosaccharide profile of the anti-TNF antibodies comprises total neutral oligosaccharide species >99.0% and total charged oligosaccharide species <1.0%. ### Claim 2 (depends on 1) The anti-TNF antibodies of claim 1, wherein the oligosaccharide profile of the anti-TNF antibodies further comprises individual neutral oligosaccharide species G0F>60.0%, G1F<20.0%, and G2F<5.0%. ### Claim 3 (depends on 1) The anti-TNF antibodies of claim 1, wherein the anti-TNF antibodies have no disialylated glycan species as determined by High Performance Liquid Chromatography (HPLC) or Reduced Mass Analysis (RMA). ### Claim 4 (depends on 1) The anti-TNF antibodies of claim 1, wherein the anti-TNF antibodies have a longer half-life or increased antibody-dependent cell-mediated cytotoxicity (ADCC) compared to anti-TNF antibodies expressed in Sp2/0 cells. ### Claim 5 A method of manufacture for producing anti-TNF antibodies comprising: (i) a heavy chain comprising the amino acid sequence of SEQ ID NO:36; and (ii) a light chain comprising the amino acid sequence of SEQ ID NO:37, wherein the anti-TNF antibodies are produced by a method of manufacture comprising: a. culturing Chinese Hamster Ovary cells (CHO cells) with nucleotides encoding the anti-TNF antibodies; b. expressing the anti-TNF antibodies in the CHO cells; and, c. purifying the anti-TNF antibodies, wherein the oligosaccharide profile of the anti-TNF antibodies comprises total neutral oligosaccharide species >99.0% and total charged oligosaccharide species <1.0%. ### Claim 6 (depends on 5) The method of manufacture of claim 5, wherein the oligosaccharide profile of the anti-TNF antibodies further comprises individual neutral oligosaccharide species G0F>60.0%, G1F<20.0%, and G2F<5.0%. ### Claim 7 (depends on 5) The method of manufacture of claim 5, wherein the anti-TNF antibodies have no disialylated glycan species as determined by High Performance Liquid Chromatography (HPLC) or Reduced Mass Analysis (RMA). ### Claim 8 (depends on 5) The method of manufacture of claim 5, wherein the anti-TNF antibodies have a longer half-life or increased antibody-dependent cell-mediated cytotoxicity (ADCC) compared to anti-TNF antibodies expressed in Sp2/0 cells. ### Claim 9 A composition comprising anti-TNF antibodies comprising: (i) a heavy chain comprising the amino acid sequence of SEQ ID NO:36; and (ii) a light chain comprising the amino acid sequence of SEQ ID NO:37, wherein the oligosaccharide profile of the anti-TNF antibodies comprises total neutral oligosaccharide species >99.0% and total charged oligosaccharide species <1.0%. ### Claim 10 (depends on 9) The composition of claim 9, wherein the oligosaccharide profile of the anti-TNF antibodies further comprises individual neutral oligosaccharide species G0F>60.0%, G1F<20.0%, and G2F<5.0%. ### Claim 11 (depends on 9) The composition of claim 9, wherein the anti-TNF antibodies have no disialylated glycan species as determined by High Performance Liquid Chromatography (HPLC). ### Claim 12 (depends on 9) The composition of claim 9, wherein the anti-TNF antibodies have a longer half-life or increased antibody-dependent cell-mediated cytotoxicity (ADCC) compared to anti-TNF antibodies expressed in Sp2/0 cells.