Office Action 1: Notice of Allowance (2025-01-29)

CLAIMS:
WHAT IS CLAIMED IS:

1\. A composition comprising an anti-1L13monoclonal antibody purified from Chinese hamster ovary host cells, wherein the composition comprises the anti-IL 13 antibody and a residual amount of hamster PLBL2, wherein the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3 ng/mg, or less than 2 ng/mg, or less than 1 ng/mg, or less than 0.5 ng/mg.

2\. The composition of claim 1, wherein the anti-IL13 antibody comprises three heavy chain CDRs, CDR-H I 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-L 1 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.

3\. The composition of claim 2, wherein the anti-IL13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7.

4\. The composition of claim 2, wherein the anti-IL13 antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.

5\. The composition of claim 3, wherein the anti-IL 13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10.

6\. The composition of claim 4, wherein the anti-IL 13 antibody comprises a light chain having the amino acid sequence of SEQ ID NO.: 14.

7\. The composition of claim 2, 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.

8\. The composition of claim 7, 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.

9\. The composition of claim 1, wherein the amount of hamster PLBL2 was quantified using an immunoassay or a mass spectrometry assay.

10\. The composition of claim 9, wherein the immunoassay is a total Chinese hamster ovary protein ELISA or a hamster PLBL2 ELISA.

11\. The composition of claim 9, wherein the mass spectrometry assay is LC-MS/MS.

12\. A purified anti-IL 13 monoclonal antibody preparation isolated from Chinese hamster ovary host cells, wherein the preparation is purified by a process comprising a hydrophobic interaction chromatography (HIC) step thereby producing a purified preparation, wherein the

purified preparation comprises the anti-IL 13 antibody and a residual amount of hamster PLBL2, wherein the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3 ng/mg, or less than 2 ng/mg, or less than 1 ng/mg, or less than 0.5 ng/mg.

13\. The anti-IL13 antibody preparation of claim 12, wherein the HIC step comprises PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin.

14\. The anti-IL 13 antibody preparation of claim 13, wherein the HIC step comprises operating a PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin-containing column in flow- through mode.

15\. The anti-IL 13 antibody preparation of claim 14, wherein the HIC step comprises an equilibration buffer and a wash buffer, wherein each of the equilibration buffer and the wash buffer comprise 50 mM sodium acetate pH 5.0.

16\. The anti-IL 13 antibody preparation of claim 15, wherein the flow-through is monitored by absorbance at 280 nanometers and the flow-through is collected between 0.5 OD to 1.5 OD.

17\. The anti-IL 13 antibody preparation of claim 15, wherein the flow-through is collected for a maximum of 8 column volumes.

18\. The anti-IL 13 antibody preparation of claim 12, wherein the process further comprises an affinity chromatography step.

19\. The anti-IL 13 antibody preparation of claim 18, wherein the affinity chromatography is protein A chromatography.

20\. The anti-IL13 antibody preparation of claim 12, wherein the process further comprises an ion exchange chromatography step.

21\. The anti-IL 13 antibody preparation of claim 20, wherein the ion exchange chromatography is anion exchange chromatography.

22\. A purified anti-IL13 monoclonal antibody preparation isolated from Chinese hamster ovary cells, wherein the antibody preparation is purified by a process comprising a first Protein A affinity chromatography step, a second anion exchange chromatography step, and a third hydrophobic interaction chromatography (HIC) step thereby producing a purified preparation, wherein the purified preparation comprises the anti-IL13 antibody and a residual amount of hamster PLBL2, wherein the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3 ng/mg, or less than 2 ng/mg, or less than 1 ng/mg, or less than 0.5 ng/mg.

23\. The anti-IL 13 antibody preparation of claim 22, wherein the affinity chromatography step comprises MABSELECT SURETM resin, the anion exchange chromatography step

comprises Q SEPHAROSETM Fast Flow resin, and the HIC step comprises PHENYL SEPHAROSETM 6 Fast Flow (high sub) resin.

24\. The anti-IL 13 antibody preparation of claim 23, wherein:the affinity chromatography step comprises operating a MABSELECT SURETM resin-containing column in bind-elute mode;
the anion exchange chromatography step comprises operating a Q SEPHAROSETMFast Flow resin-containing column in bind-elute mode; and
the HIC step comprises operating a PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin-containing column in flow-through mode.

25\. The anti-IL 13 antibody preparation of claim 12 or claim 22, wherein the anti-IL 13 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.

26\. The anti-IL 13 antibody preparation of claim 25, wherein the anti-IL 13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7.

27\. The anti-IL 13 antibody preparation of claim 25, wherein the anti-IL 13 antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.

28\. The anti-IL13 antibody preparation of claim 26, wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10.

29\. The anti-IL 13 antibody preparation of claim 27, wherein the anti-IL 13 antibody comprises a light chain having the amino acid sequence of SEQ ID NO.: 14.

30\. The anti-IL 13 antibody preparation of claim 25, wherein the anti-IL 13 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.

31\. The anti-IL 13 antibody preparation of claim 30, wherein the anti-IL 13 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.

32\. The anti-IL 13 antibody preparation of claim 12 or claim 22, wherein the amount of hamster PLBL2 was quantified using an immunoassay or a mass spectrometry assay.

33\. The anti-IL 13 antibody preparation of claim 32, wherein the immunoassay is a total Chinese hamster ovary protein ELISA or a hamster PLBL2 ELISA.

34\. The anti-IL 13 antibody preparation of claim 32, wherein the mass spectrometry assay is LC-MS/MS.

35\. A method of purifying a recombinant polypeptide produced in Chinese hamster ovary host cells, wherein the method provides a purified preparation comprising the recombinant polypeptide and a residual amount of hamster PLBL2.

36\. The method of claim 35, wherein the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3 ng/mg, or less than 2 ng/mg, or less than l ng/mg, or less than 0.5 ng/mg.

37\. The method of claim 36 comprising a hydrophobic interaction chromatography (HIC) step.

38\. The method of claim 37, wherein the HIC step comprises PHENYL SEPHAROSETM6 Fast Flow (High Sub) resin.

39\. The method of claim 38, wherein the HIC step comprises operating a PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin-containing column in flow-through mode.

40\. The method of claim 37, wherein the recombinant polypeptide is selected from a growth factor, a cytokine, an antibody, an antibody fragment, and an immunoadhesin.

41\. The method of claim 40, wherein the recombinant polypeptide is an antibody.

42\. The method of claim 41, wherein the antibody is a humanized monoclonal antibody.

43\. The method of claim 42, wherein the antibody is IgGl, or IgG2, or IgG3, or IgG4.

44\. The method of claim 43, wherein the antibody is IgG4.

45\. The method of claim 41, wherein the antibody is anti-IL13.

46\. The method of claim 44, wherein the antibody is lebrikizumab.

47\. The method of claim 45, wherein the anti-IL 13 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-L 1 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.

48\. The method of any one of claims 45, 46, or 47, wherein the HIC step comprises operating a resin-containing column in flow-through mode and an equilibration buffer and a wash buffer, wherein each of the equilibration buffer and the wash buffer comprise 50 mM sodium acetate pH 5.0.

49\. The method of claim 48, wherein the flow-through is monitored by absorbance at 280 nanometers and the flow-through is collected between 0.5 OD to 1.5 OD.

50\. The method of claim 48, wherein the flow-through is collected for a maximum of 8 column volumes.

51\. The method of claim 48, further comprising an affinity chromatography step.

52\. The method of claim 51, wherein the affinity chromatography is protein A chromatography.

53\. The method of claim 48, further comprising an ion exchange chromatography step.

54\. The method of claim 53, wherein the ion exchange chromatography is anion exchange chromatography.

55\. The method of claim 48 comprising a first Protein A affinity chromatography step and a second anion exchange chromatography step prior to the hydrophobic interaction chromatography (HIC) step.

56\. The method of claim 55, wherein the affinity chromatography step comprises MABSELECT SURETM resin, the anion exchange chromatography step comprises Q SEPHAROSETM Fast Flow, and the HIC step comprises PHENYL SEPHAROSETM 6 Fast Flow (high sub).

57\. The method of claim 56, wherein:the affinity chromatography step comprises operating a MABSELECT SURETM resin-containing column in bind-elute mode;
the anion exchange chromatography step comprises operating a Q SEPHAROSETM Fast Flow resin-containing column in bind-elute mode, and
the HIC step comprises operating a PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin-containing column in flow-through mode.

58\. The method of claim 41, wherein the antibody is anti-Abeta.

59\. The method of claim 44, wherein the antibody is crenezurnab.

60\. The method of claim 58, wherein the anti-Abeta antibody comprises three heavy chain CDRs, CDR-H I having the amino acid sequence of SEQ ID NO.:23, CDR-H2 having the amino acid sequence of SEQ ID NO.:24, and CDR-H3 having the amino acid sequence of SEQ ID NO.:25, and three light chain CDRs, CDR-L 1 having the amino acid sequence of SEQ ID NO.:26, CDR-L2 having the amino acid sequence of SEQ ID NO.:27, and CDR-L3 having the amino acid sequence of SEQ ID NO.:28.

61\. The method of any one of claims 58, 59, or 60, wherein the HIC step comprises operating a resin-containing column in flow-through mode and an equilibration buffer and a wash buffer, wherein each of the equilibration buffer and the wash buffer comprise 150 mM sodium acetate pH 5.0.

62\. The method of claim 61, wherein the flow-through is monitored by absorbance at 280 nanometers and the flow-through is collected beginning at 0.5 OD and for 10 column volumes.

63\. The method of claim 61, further comprising an affinity chromatography step.

64\. The method of claim 63, wherein the affinity chromatography is protein A chromatography.

65\. The method of claim 61, further comprising a mixed mode chromatography step.

66\. The method of claim 61 comprising a first Protein A affinity chromatography step and a second mixed mode chromatography step prior to the hydrophobic interaction chromatography (HIC) step.

67\. The method of claim 66, wherein the affinity chromatography step comprises MABSELECT SURETM resin, the mixed mode chromatography step comprises CAPTOTM Adhere, and the HIC step comprises PHENYL SEPHAROSETM 6 Fast Flow (high sub).

68\. The method of claim 67, wherein:the affinity chromatography step comprises operating a MABSELECT SURETM resin-containing column in bind-elute mode;
the mixed mode chromatography step comprises operating a CAPTOTM Adhere resin-containing column in flow-through mode, and
the HIC step comprises operating a PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin-containing column in flow-through mode.

69\. The method of claim 36, wherein the amount of hamster PLBL2 is quantified using an immunoassay or a mass spectrometry assay.

70\. The method of claim 69, wherein the immunoassay is a total Chinese hamster ovary protein ELISA or a hamster PLBL2 ELISA.

71\. The method of claim 69, wherein the mass spectrometry assay is LC-MS/MS.

72\. A composition comprising an anti-Abeta monoclonal antibody purified from Chinese hamster ovary host cells, wherein the composition comprises the anti-Abeta antibody and a residual amount of hamster PLBL2, wherein the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3 ng/mg, or less than 2 ng/mg, or less than I ng/mg, or less than 0.5 ng/mg.

73\. The composition of claim 72, wherein the anti-Abeta antibody is crenezumab.

74\. The composition of claim 72, wherein the anti-Abeta antibody comprises three heavy chain CDRs, CDR-H1 having the amino acid sequence of SEQ ID NO.:23, CDR-H2 having the amino acid sequence of SEQ ID NO.:24, and CDR-H3 having the amino acid sequence of SEQ ID NO.:25, and three light chain CDRs, CDR-L1 having the amino acid sequence of SEQ ID

NO.:26, CDR-L2 having the amino acid sequence of SEQ ID NO.:27, and CDR-L3 having the amino acid sequence of SEQ ID NO.:28.

75\. The composition of claim 74, wherein the anti-Abeta antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.:29.

76\. The composition of claim 74, wherein the anti-Abeta antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.:30.

77\. The composition of claim 74, wherein the anti-Abeta antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.:29 and a light chain variable region having the amino acid sequence of SEQ ID NO.:30.

78\. The method of claim 43, wherein the antibody is IgG1.

79\. The method of claim 41, wherein the antibody is anti-IL17 A/F.

80\. The method of claim 79, wherein the antibody comprises three heavy chain CDRs, CDR- H1 having the amino acid sequence of SEQ ID NO.: 15, CDR-H2 having the amino acid sequence of SEQ ID NO.:16, and CDR-H3 having the amino acid sequence of SEQ ID NO.:17, and three light chain CDRs, CDR-L1 having the amino acid sequence of SEQ ID NO.:18, CDR- L2 having the amino acid sequence of SEQ ID NO.:19 and CDR-L3 having the amino acid sequence of SEQ ID NO.:20.

81\. The method of claim 79 or claim 80, wherein the HIC step comprises operating a resin- containing column in flow-through mode and an equilibration buffer and a wash buffer, wherein each of the equilibration buffer and the wash buffer comprise 50 mM sodium acetate pH 5.5.

82\. The method of claim 81, wherein the flow-through is monitored by absorbance at 280 nanometers and the flow-through is collected beginning at 0.5 OD and for 10 column volumes.

83\. The method of claim 81, further comprising an affinity chromatography step.

84\. The method of claim 83, wherein the affinity chromatography is protein A chromatography.

85\. The method of claim 81, further comprising a cation exchange chromatography step.

86\. The method of claim 81 comprising a first Protein A affinity chromatography step and a second cation exchange chromatography step prior to the hydrophobic interaction chromatography (HIC) step.

87\. The method of claim 86, wherein the affinity chromatography step comprises MABSELECT SURETM resin, the cation exchange chromatography step comprises POROS@50HS resin, and the HIC step comprises PHENYL SEPHAROSETM 6 Fast Flow (high sub) resin.

88\. The method of claim 87, wherein:

the affinity chromatography step comprises operating a MABSELECT SURETM resin-containing column in bind-elute mode;
the cation exchange chromatography step comprises operating a POROS@50HS resin-containing column in bind-elute mode, and
the HIC step comprises operating a PHENYL SEPHAROSETM 6 Fast Flow (High Sub) resin-containing column in flow-through mode.

89\. A composition comprising an anti-IL17 A/F monoclonal antibody purified from Chinese hamster ovary host cells, wherein the composition comprises the anti-IL 17 A/F antibody and a residual amount of hamster PLBL2, wherein the amount of hamster PLBL2 is less than 20 ng/mg, or less than 15 ng/mg, or less than 10 ng/mg, or less than 8 ng/mg, or less than 5 ng/mg, or less than 3 ng/mg, or less than 2 ng/mg, or less than 1 ng/mg, or less than 0.5 ng/mg.

90\. The composition of claim 89, wherein the anti-IL17 A/F antibody comprises three heavy chain CDRs, CDR-H1 having the amino acid sequence of SEQ ID NO.: 15, CDR-H2 having the amino acid sequence of SEQ ID NO.:16, and CDR-H3 having the amino acid sequence of SEQ ID NO.:17, and three light chain CDRs, CDR-L1 having the amino acid sequence of SEQ ID NO.:18, CDR-L2 having the amino acid sequence of SEQ ID NO.:19, and CDR-L3 having the amino acid sequence of SEQ ID NO.:20.

91\. The composition of claim 90, wherein the anti-IL 17 A/F antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.:21.

92\. The composition of claim 90, wherein the anti-1L17 A/F antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.:22.

93\. The composition of claim 90, wherein the anti-IL 17 A/F antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.:21 and a light chain variable region having the amino acid sequence of SEQ ID NO.:22.

94\. A method of treating an IL-13-mediated disorder in a patient comprising administering a treatment composition to the patient, wherein the treatment composition comprises the composition of any one of claims 1-8.

95\. The method of claim 94, 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 30 ng/mg, or greater than 50 ng/mg, or greater than 100 ng/mg, or greater than 200 ng/mg, or greater than 300 ng/mg.

96\. The method claim 94, wherein the treatment composition is administered subcutaneously once every four weeks, or once every eight weeks, or once every 12 weeks.

97\. The method of claim 96, wherein the patient is treated once every four weeks for at least one month, or at least three months, or at least six months, or at least nine months, or at least twelve months, or at least 18 months, or at least two years, or more than two years.

98\. The method of claim 94, wherein the IL-13-mediated disorder is selected from asthma, idiopathic pulmonary fibrosis and atopic dermatitis.

99\. The method of claim 94, wherein the IL-I 3-mediated disorder is selected from allergic asthma, non-allergic asthma, allergic rhinitis, allergic conjunctivitis, eczema, urticaria, food allergies, chronic obstructive pulmonary disease, ulcerative colitis, RSV infection, uveitis, scleroderma, and osteoporosis.

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amended claims 1, 3-4, 7, (4/21/2023), and original claims 5-6, 8-11, are pending and under consideration by the Examiner.
Claims 2, and 12-99 have been canceled.
Information Disclosure Statement
3.	The information disclosure statement (IDS) submitted on 4/21/2023, is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56.  As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
The terminal disclaimer submitted on 12/16/2024 obviates the non-statutory double patenting rejection over US Patent No. 10,597,447.
5.	Applicant’s Request for Correction of Inventorship under 37CFR 1.48 submitted on 12/17/2024 is acknowledged and the inventorship has been corrected.
6.	An Examiner's Amendment to the record appears below.  Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 C.F.R. § 1.312.  To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the Issue Fee.
Authorization for this Examiner's Amendment was given in a telephone interview with Amy Schoenhard on 12/13/2024.
7.	The application has been amended as follows:
IN THE CLAIMS:
Claim 9. (Currently Amended) The composition of claim 1, wherein the amount of hamster PLBL2 was quantified by an immunoassay or a mass spectrometry assay.
8.	Claims 1, and 3-11 are allowable.
9.	The following is an Examiner's Statement of Reasons for Allowance:
None of the prior art of record describe or suggest a composition comprising an anti-IL13 monoclonal antibody purified from Chinese hamster ovary host cells and less than 20 ng/mg of hamster phospholipase B-like 2 (PLBL2), 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.
Furthermore, the claimed invention meets the requirements of 35 USC § 101 and 35 USC § 112 in that the composition comprises an IL-13 monoclonal antibody of sufficient purity (including removal of PLBL2) for human therapeutic use including late-stage clinical and commercial use.
10.	Any comments considered necessary by applicant must be submitted no later than the payment of the Issue Fee and, to avoid processing delays, should preferably accompany the Issue Fee.  Such submissions should be clearly labeled Comments on Statement of Reasons for Allowance.
Advisory Information



CITED REFERENCE SUMMARIES: Ref US10597447: Claims:
1. 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), wherein the residual amount of hamster PLBL2 is 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 composition of claim 1, wherein the anti-IL13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7.
3. The composition of claim 1, wherein the anti-IL13 antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.
4. The composition of claim 2, wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10.
5. The composition of claim 3, wherein the anti-IL13 antibody comprises a light chain having the amino acid sequence of SEQ ID NO.: 14.
6. The composition 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.
7. The composition of claim 6, 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.
8. The composition of claim 1, wherein the amount of hamster PLBL2 was quantified using an immunoassay or a mass spectrometry assay.
9. The composition of claim 8, wherein the immunoassay is a total Chinese hamster ovary protein ELISA or a hamster PLBL2 ELISA.
10. The composition of claim 8, wherein the mass spectrometry assay is LC-MS/MS.
11. A purified anti-IL13 monoclonal antibody preparation isolated from Chinese hamster ovary host cells, wherein the preparation is purified by a process comprising a hydrophobic interaction chromatography (HIC) step thereby producing a purified preparation, wherein the purified preparation comprises the anti-IL13 antibody and a residual amount of hamster PLBL2, wherein the residual amount of hamster PLBL2 is 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.
12. The anti-IL13 antibody preparation of claim 11, wherein the HIC step comprises PHENYL SEPHAROSE™ 6 Fast Flow (High Sub) resin.
13. The anti-IL13 antibody preparation of claim 12, wherein the HIC step comprises operating a PHENYL SEPHAROSE™ 6 Fast Flow (High Sub) resin-containing column in flow-through mode.
14. The anti-IL13 antibody preparation of claim 13, wherein the HIC step comprises an equilibration buffer and a wash buffer, wherein each of the equilibration buffer and the wash buffer comprise 50 mM sodium acetate pH 5.0.
15. The anti-IL13 antibody preparation of claim 14, wherein the flow-through is monitored by absorbance at 280 nanometers and the flow-through is collected between 0.5 OD to 1.5 OD.
16. The anti-IL13 antibody preparation of claim 14, wherein the flow-through is collected for a maximum of 8 column volumes.
17. The anti-IL13 antibody preparation of claim 11, wherein the process further comprises an affinity chromatography step and/or an ion exchange chromatography step.
18. The anti-IL13 antibody preparation of claim 17, wherein the affinity chromatography is protein A chromatography.
19. The anti-IL13 antibody preparation of claim 17, wherein the ion exchange chromatography is anion exchange chromatography.
20. A purified anti-IL13 monoclonal antibody preparation isolated from Chinese hamster ovary cells, wherein the antibody preparation is purified by a process comprising a first Protein A affinity chromatography step, a second anion exchange chromatography step, and a third hydrophobic interaction chromatography (HIC) step thereby producing a purified preparation, wherein the purified preparation comprises the anti-IL13 antibody and a residual amount of hamster PLBL2, wherein the amount of hamster PLBL2 is 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.
21. The anti-IL13 antibody preparation of claim 20, wherein the affinity chromatography step comprises MABSELECT SURE™ resin, the anion exchange chromatography step comprises Q SEPHAROSE™ Fast Flow resin, and the HIC step comprises PHENYL SEPHAROSE™ 6 Fast Flow (high sub) resin.
22. The anti-IL13 antibody preparation of claim 21, wherein:
the affinity chromatography step comprises operating a MABSELECT SURE™ resin-containing column in bind-elute mode;
the anion exchange chromatography step comprises operating a Q SEPHAROSE™ Fast Flow resin-containing column in bind-elute mode; and
the HIC step comprises operating a PHENYL SEPHAROSE™ 6 Fast Flow (High Sub) resin-containing column in flow-through mode.
23. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 15 ng/mg.
24. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 10 ng/mg.
25. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 8 ng/mg.
26. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 5 ng/mg.
27. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 3 ng/mg.
28. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 2 ng/mg.
29. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 1 ng/mg.
30. The composition of claim 1, wherein the residual amount of hamster PLBL2 is less than 0.5 ng/mg.
31. The purified anti-IL13 monoclonal antibody preparation of claim 11, 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.
32. The purified anti-IL13 monoclonal antibody preparation of claim 11, 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.
33. The purified anti-IL13 monoclonal antibody preparation of claim 11, wherein the residual amount of hamster PLBL2 is less than 5 ng/mg.
34. The purified anti-IL13 monoclonal antibody preparation of claim 20, 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.
35. The purified anti-IL13 monoclonal antibody preparation of claim 20, 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.
36. The purified anti-IL13 monoclonal antibody preparation of claim 20, wherein the residual amount of hamster PLBL2 is less than 5 ng/mg.