IP Library › Granted Patent US 12,492,247
Granted Patent B2
US 12,492,247 · App. 17/167,754 · Granted Dec 9, 2025

Antibody formulations

Inventors: Ajay Deshmukh (San Francisco, CA); Thomas M. Scherer (San Carlos, CA); Joumana Zeid (Oakland, CA)
Assignee: GENENTECH, INC.
C07K16/244A61K9/0019A61K47/183A61K47/26A61M5/24A61P37/08A61K39/39591C07K2317/24C07K2317/94
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Quick Facts
Patent No.
US 12,492,247
App. No.
17/167,754
Granted
Dec 9, 2025
Kind
B2
Abstract

Formulations comprising an anti-IL-13 antibody are provided, including pharmaceutical formulations and methods of using such formulations.

Claims (24)

1 . A formulation comprising an anti-IL13 antibody, wherein the concentration of the anti-IL13 antibody in the formulation is between 100 mg/mL and 150 mg/mL and the viscosity of the formulation is less than 15 centipoise (cP) at 25° C., wherein the formulation comprises a histidine acetate buffer, pH 5.4 to 6.0, and the histidine acetate concentration in the buffer is between 5 mM and 40 mM, and wherein the anti-IL-13 antibody is an IgG4 antibody and 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 formulation 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.

3 . The formulation of claim 1 , 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.

4 . The formulation of claim 1 , wherein the concentration of antibody is 125 mg/mL.

5 . The formulation of claim 1 , wherein the concentration of antibody is 150 mg/mL.

6 . The formulation of claim 1 , further comprising a polyol and a surfactant, wherein the concentration of the polyol in the formulation is between 100 mM and 200 mM and the concentration of the surfactant in the formulation is between 0.01% and 0.1%.

7 . The formulation of claim 6 , wherein the polyol is sucrose and the surfactant is polysorbate 20.

8 . The formulation of claim 7 , wherein the histidine acetate buffer is pH 5.7 and the histidine acetate concentration in the buffer is 20 mM, and wherein the concentration of sucrose in the formulation is 175 mM and the concentration of polysorbate 20 is 0.03%.

9 . The formulation of claim 1 , wherein the formulation has extended stability.

10 . An article of manufacture comprising the formulation of claim 1 and a subcutaneous administration device.

11 . The article of manufacture of claim 10 , wherein the subcutaneous administration device comprises a prefilled syringe.

12 . The article of manufacture of claim 11 , wherein the prefilled syringe comprises a glass barrel, a needle, and a needle shield.

13 . The article of manufacture of claim 12 further comprising a plunger rod and a plunger stopper.

14 . The article of manufacture of claim 13 further comprising a needle safety device.

15 . The article of manufacture of claim 13 , wherein the plunger stopper comprises 4023/50 rubber and ethylene-tetrafluoroethylene coating.

16 . The article of manufacture of claim 12 , wherein the glass barrel comprises borosilicate glass and contains about 0.3 mL, about 1.0 mL, or about 2.0 mL of the formulation.

17 . The article of manufacture of claim 12 , wherein the needle is staked-in, stainless steel, 27 G thin-wall, ½ inch long, and 5-bevel tip.

18 . The article of manufacture of claim 12 , wherein the needle shield is rigid and comprises an elastomeric component, FM27/0, and rigid polypropylene shield.

19 . A formulation comprising an anti-IL13 antibody having extended stability in 20 mM histidine acetate buffer, pH 5.7, 175 mM sucrose, 0.03% polysorbate 20, wherein the concentration of antibody in the formulation is 125 mg/mL and the viscosity of the formulation is less than 15 centipoise (cP) at 25° C., and wherein the anti-IL13 antibody is an IgG4 antibody and 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.

20 . The formulation of claim 19 , 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.

21 . The formulation of claim 19 , 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.

22 . A formulation comprising an anti-IL13 antibody having extended stability in 20 mM histidine acetate buffer, pH 5.7, 175 mM sucrose, 0.03% polysorbate 20, wherein the concentration of antibody in the formulation is 150 mg/mL and the viscosity of the formulation is less than 15 centipoise (cP) at 25° C., and wherein the anti-IL13 antibody is an IgG4 antibody and 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.

23 . The formulation of claim 22 , 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.

24 . The formulation of claim 22 , 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 4, 2021
From: DESHMUKH, AJAY; SCHERER, THOMAS M; ZEID, JOUMANA
To: GENENTECH, INC.
Reel/Frame 055152/0262 →
Continuity (5)
Continuation 16002932 · Jun 7, 2018
Division 14259882 · Apr 23, 2014
Continuation PCTUS2012062572 · Oct 30, 2012
Provisional Application 61553916 · Oct 31, 2011
Related Publication 20210155684A1 · May 27, 2021
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