Method of treatment comprising purified recombinant IL-13 antibody
Purified recombinant polypeptides isolated from Chinese hamster ovary host cells, including antibodies, such as therapeutic antibodies, and methods of making and using such polypeptides are provided.
1. A method of treating an IL13 mediated disorder selected from asthma, idiopathic pulmonary fibrosis, and atopic dermatitis in a patient comprising administering a treatment composition to the patient, wherein the treatment composition comprises a composition comprising an anti-IL13 monoclonal antibody purified from Chinese hamster ovary host cells, wherein the composition comprises the anti-IL13 antibody and a residual amount of hamster phospholipase B-like 2 (PLBL2) of less than 20 ng/mg, wherein the anti-IL13 antibody comprises three heavy chain CDRs, CDR-H1 having the amino acid sequence of SEQ ID NO.: 1, CDR-H2 having the amino acid sequence of SEQ ID NO.: 2, and CDR-H3 having the amino acid sequence of SEQ ID NO.: 3, and three light chain CDRs, CDR-L1 having the amino acid sequence of SEQ ID NO.: 4, CDR-L2 having the amino acid sequence of SEQ ID NO.: 5, and CDR-L3 having the amino acid sequence of SEQ ID NO.: 6.
2. The method of claim 1 , wherein administration of the treatment composition is less immunogenic for hamster PLBL2 compared to administration of a reference composition, wherein the reference composition comprises an anti-IL13 monoclonal antibody purified from Chinese hamster ovary host cells and a residual amount of hamster PLBL2 of greater than 100 ng/mg.
3. The method of claim 1 , wherein the treatment composition is administered subcutaneously once every four weeks, once every eight weeks, or once every 12 weeks.
4. The method of claim 3 , wherein the patient is treated once every four weeks for at least one month.
5. The method of claim 1 , wherein the asthma is allergic asthma or non-allergic asthma.
6. The method of claim 1 , wherein the anti-IL13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7.
7. The method of claim 1 , wherein the anti-IL13 antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.
8. The method of claim 6 , wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10.
9. The method of claim 7 , wherein the anti-IL13 antibody comprises a light chain having the amino acid sequence of SEQ ID NO.: 14.
10. The method of claim 1 , wherein the anti-IL13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7 and a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.
11. The method of claim 10 , wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10 and a light chain having the amino acid sequence of SEQ ID NO.: 14.
12. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 15 ng/mg.
13. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 10 ng/mg.
14. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 8 ng/mg.
15. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 5 ng/mg.
16. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 3 ng/mg.
17. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 2 ng/mg.
18. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 1 ng/mg.
19. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 0.5 ng/mg.
20. The method of claim 2 , wherein the residual amount of hamster PLBL2 in the reference composition is greater than 200 ng/mg.
21. The method of claim 2 , wherein the residual amount of hamster PLBL2 in the reference composition is greater than 300 ng/mg.