US2020291107A1PendingUtilityA1

Manufacturing Methods for Producing Anti-IL12/IL23 Antibody Compositions

Assignee: JANSSEN BIOTECH INCPriority: Mar 14, 2019Filed: Mar 12, 2020Published: Sep 17, 2020

Est. expiryMar 14, 2039(~12.6 yrs left)· nominal 20-yr term from priority

Inventors:Kristopher Barnthouse Subinay Ganguly Maarten Groeneveld Manuel Lopez, Jr.Michael Nedved Kevin D. Smith

C07K 2317/565C07K 2317/56C07K 2317/31C07K 16/244C07K 2317/22C07K 2317/41C12N 5/0682C07K 1/18C07K 2317/21C07K 2317/14

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References

Claims

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.

Claims

exact text as granted — not AI-modified

What is claimed: 
     
         1 . An isolated 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 expressed in a Chinese Hamster Ovary cell (CHO cell). 
     
     
         2 . The anti-IL-12/IL-23p40 antibody of  claim 1 , wherein the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody comprises total neutral oligosaccharide species &gt;99.0% and total charged oligosaccharide species &lt;1.0% 
     
     
         3 . The anti-IL-12/IL-23p40 antibody of  claim 2 , wherein the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody further comprises individual neutral oligosaccharide species G0F&gt;70.0%, G1F&lt;20.0%, and G2F&lt;5.0%. 
     
     
         4 . The anti-IL-12/IL-23p40 antibody of  claim 2 , wherein the peak 3 area % of the capillary isoelectric focusing (cIEF) electropherogram of the anti-IL-12/IL-23p40 antibody is &gt;70.0%. 
     
     
         5 . The anti-IL-12/IL-23p40 antibody of  claim 2 , wherein the anti-IL-12/IL-23p40 antibody has no disialylated glycan species as determined by High Performance Liquid Chromatography (HPLC) or Reduced Mass Analysis (RMA). 
     
     
         6 . The anti-IL-12/IL-23p40 antibody of  claim 2 , wherein the anti-IL-12/IL-23p40 antibody has a longer half-life compared to an anti-IL-12/IL-23p40 antibody with identical amino acid heavy chain and light chain sequences expressed in Sp2/0 cells. 
     
     
         7 . The anti-IL-12/IL-23p40 antibody of  claim 2 , wherein the anti-IL-12/IL-23p40 antibody comprises a follow-on biologic. 
     
     
         8 . 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; and   c. purifying the anti-IL-12/IL-23p40 antibody.   
     
     
         9 . The method of manufacture of  claim 8 , wherein the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody comprises total neutral oligosaccharide species &gt;99.0% and total charged oligosaccharide species &lt;1.0%. 
     
     
         10 . The method of manufacture of  claim 9 , wherein the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody further comprises individual neutral oligosaccharide species G0F&gt;70.0%, G1F&lt;20.0%, and G2F&lt;5.0%. 
     
     
         11 . The method of manufacture of  claim 9 , wherein the peak 3 area % of the capillary isoelectric focusing (cIEF) electropherogram of the anti-IL-12/IL-23p40 antibody is &gt;70.0%. 
     
     
         12 . The method of manufacture of  claim 9 , wherein the anti-IL-12/IL-23p40 antibody has no disialylated glycan species as determined by High Performance Liquid Chromatography (HPLC) or Reduced Mass Analysis (RMA). 
     
     
         13 . The method of manufacture of  claim 9 , wherein the anti-IL-12/IL-23p40 antibody has a longer half-life compared to an anti-IL-12/IL-23p40 antibody with identical amino acid heavy chain and light chain sequences expressed in Sp2/0 cells. 
     
     
         14 . The method of manufacture of  claim 9 , wherein the anti-IL-12/IL-23p40 antibody is a follow-on biologic. 
     
     
         15 . A composition comprising 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 expressed in a Chinese Hamster Ovary cell (CHO cell). 
     
     
         16 . The composition of  claim 15 , wherein the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody comprises total neutral oligosaccharide species &gt;99.0% and total charged oligosaccharide species &lt;1.0%. 
     
     
         17 . The composition of  claim 16 , wherein the oligosaccharide profile of the anti-IL-12/IL-23p40 antibody further comprises individual neutral oligosaccharide species G0F&gt;70.0%, G1F&lt;20.0%, and G2F&lt;5.0%. 
     
     
         18 . The composition of  claim 16 , wherein the peak 3 area % of the capillary isoelectric focusing (cIEF) electropherogram of the anti-IL-12/IL-23p40 antibody is &gt;70.0%. 
     
     
         19 . The composition of  claim 16 , wherein the anti-IL-12/IL-23p40 antibody has no disialylated glycan species as determined by High Performance Liquid Chromatography (HPLC). 
     
     
         20 . The composition of  claim 16 , wherein the anti-IL-12/IL-23p40 antibody has a longer half-life compared to an anti-IL-12/IL-23p40 antibody with identical amino acid heavy chain and light chain sequences expressed in Sp2/0 cells. 
     
     
         21 . The composition of  claim 16 , wherein the anti-IL-12/IL-23p40 antibody is a follow-on biologic.

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