Anti-CD40 Antibody Formulations
Provided herein, in some aspects, are low viscosity, low aggregation propensity, high anti-CD40 antibody concentration formulations.
1 . An anti-CD40 antibody formulation, comprising:
anti-CD40 antibody;
10 mM to 30 mM citrate; and
140 mM to 160 mM arginine, wherein the formulation in solution has a pH value of 5.0 to 6.5.
2 . The anti-CD40 antibody formulation of claim 1 , wherein the formulation has an anti-CD40 antibody concentration of 100 mg/ml to 300 mg/ml.
3 . The anti-CD40 antibody formulation of claim 1 , wherein the formulation has an anti-CD40 antibody concentration of at least 150 mg/ml.
4 . The anti-CD40 antibody formulation of claim 3 , wherein the formulation has an anti-CD40 antibody concentration of at least 200 mg/ml.
5 . The anti-CD40 antibody formulation of claim 4 , wherein the formulation has an anti-CD40 antibody concentration of at least 250 mg/ml.
6 . The anti-CD40 antibody formulation of any one of claims 1 - 5 , wherein the formulation has an anti-CD40 antibody concentration of 250 mg/ml.
7 . The anti-CD40 antibody formulation of any one of claims 1 - 6 , wherein the anti-CD40 antibody is a monoclonal antibody.
8 . The anti-CD40 antibody formulation of any one of claims 1 - 7 , wherein the formulation has a citrate concentration of 20 mM.
9 . The anti-CD40 antibody formulation of any one of claims 1 - 8 , wherein the formulation has an arginine concentration of 150 mM.
10 . The anti-CD40 antibody formulation of any one of claims 1 - 9 , wherein the formulation has a pH value of 5.5-6.0.
11 . The anti-CD40 antibody formulation of claim 10 , wherein the formulation has a pH value of 5.7.
12 . The anti-CD40 antibody formulation of any one of claims 1 - 11 , further comprising sucrose.
13 . The anti-CD40 antibody formulation of claim 12 , wherein the formulation has a sucrose concentration of 200 mM to 400 mM.
14 . The anti-CD40 antibody formulation of claim 13 , wherein the formulation has a sucrose concentration of 300 mM.
15 . The anti-CD40 antibody formulation of any one of claims 1 - 14 , wherein the increase in the percentage of high molecular weight species present in the formulation after storage for one month at 40° C. is less than 4.
16 . The anti-CD40 antibody formulation of any one of claims 1 - 15 , wherein the formulation has a viscosity suitable for subcutaneous injection.
17 . The anti-CD40 antibody formulation of any one of claims 1 - 16 , wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge.
18 . The anti-CD40 antibody formulation of any one of claims 1 - 17 , wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge while at a temperature in range of 25° C. to 40° C.
19 . The anti-CD40 antibody formulation of any one of claims 1 - 18 , wherein the formulation has a viscosity of less than 40 cP at anti-CD40 antibody concentrations of up to 250 mg/ml.
20 . An anti-CD40 antibody formulation, comprising:
100 mg/ml to 250 mg/ml anti-CD40 antibody; and
buffer having a pH value of 5.5 to 6.0.
21 . The anti-CD40 antibody formulation of claim 20 , wherein the buffer is a citrate buffer.
22 . The anti-CD40 antibody formulation of claim 21 , wherein the citrate buffer has a concentration of 10 mM to 30 mM.
23 . The anti-CD40 antibody formulation of claim 22 , wherein the citrate buffer has a concentration of 20 mM.
24 . The anti-CD40 antibody formulation of any one of claims 20 - 23 , further comprising arginine.
25 . The anti-CD40 antibody formulation of claim 24 , wherein the arginine is present at a concentration of 140 mM to 160 mM.
26 . The anti-CD40 antibody formulation of claim 25 , wherein the arginine is present at a concentration of 150 mM.
27 . The anti-CD40 antibody formulation of any one of claims 20 - 26 , further comprising sucrose.
28 . The anti-CD40 antibody formulation of claim 27 , wherein the sucrose is present at a concentration of 200 mM to 400 mM.
29 . The anti-CD40 antibody formulation of claim 28 , wherein the sucrose is present at a concentration of 300 mM.
30 . An anti-CD40 antibody formulation, comprising:
at least 150 mg/ml anti-CD40 antibody;
20 mM buffer containing sodium citrate and citric acid; and
150 mM arginine, wherein the formulation has a pH value of 5.5 to 6.0.
31 . The anti-CD40 antibody formulation of claim 30 , further comprising 300 mM sucrose.
32 . A method of producing an anti-CD40 antibody formulation, the method comprising:
combining 100 mg/ml to 300 mg/ml anti-CD40 antibody in citrate buffer; and
adjusting pH of the formulation to 5.0 to 6.5.
33 . The method of claim 32 , wherein the citrate buffer has a concentration of 10 mM to 30 mM.
34 . The method of claim 33 , wherein the citrate buffer has a concentration of 20 mM.
35 . An anti-CD40 antibody formulation, comprising:
anti-CD40 antibody;
10 mM to 30 mM histidine; and
140 mM to 160 mM arginine, wherein the formulation in solution has a pH value of 5.0-6.5.
36 . The anti-CD40 antibody formulation of claim 35 , wherein the formulation has an anti-CD40 antibody concentration of 100 mg/ml to 300 mg/ml.
37 . The anti-CD40 antibody formulation of claim 35 , wherein the formulation has an anti-CD40 antibody concentration of at least 150 mg/ml.
38 . The anti-CD40 antibody formulation of claim 37 , wherein the formulation has an anti-CD40 antibody concentration of at least 200 mg/ml.
39 . The anti-CD40 antibody formulation of claim 38 , wherein the formulation has an anti-CD40 antibody concentration of at least 250 mg/ml.
40 . The anti-CD40 antibody formulation of any one of claims 35 - 39 , wherein the formulation has an anti-CD40 antibody concentration of 250 mg/ml.
41 . The anti-CD40 antibody formulation of any one of claims 35 - 40 , wherein the anti-CD40 antibody is a monoclonal antibody.
42 . The anti-CD40 antibody formulation of any one of claims 35 - 41 , wherein the formulation has a histidine concentration of 20 mM.
43 . The anti-CD40 antibody formulation of any one of claims 35 - 42 , wherein the formulation has an arginine concentration of 150 mM.
44 . The anti-CD40 antibody formulation of any one of claims 35 - 43 , wherein the formulation has a pH value of 5.5-6.0.
45 . The anti-CD40 antibody formulation of claim 44 , wherein the formulation has a pH value of 5.7.
46 . The anti-CD40 antibody formulation of any one of claims 35 - 45 , further comprising sucrose.
47 . The anti-CD40 antibody formulation of claim 46 , wherein the formulation has a sucrose concentration of 200 mM to 400 mM.
48 . The anti-CD40 antibody formulation of claim 47 , wherein the formulation has a sucrose concentration of 300 mM.
49 . The anti-CD40 antibody formulation of any one of claims 35 - 48 , wherein the increase in the percentage of high molecular weight species present in the formulation after storage for one month at 40° C. is less than 4.
50 . The anti-CD40 antibody formulation of any one of claims 35 - 49 , wherein the formulation has a viscosity suitable for subcutaneous injection.
51 . The anti-CD40 antibody formulation of any one of claims 35 - 50 , wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge.
52 . The anti-CD40 antibody formulation of any one of claims 35 - 51 , wherein the formulation has a viscosity suitable for injection through a needle having a size of 29 gauge to 31 gauge while at a temperature in range of 25° C. to 40° C.
53 . The anti-CD40 antibody formulation of any one of claims 35 - 52 , wherein the formulation has a viscosity of less than 40 cP at anti-CD40 antibody concentrations of up to 250 mg/ml.
54 . An anti-CD40 antibody formulation, comprising:
100 mg/ml to 250 mg/ml anti-CD40 antibody; and
buffer having a pH value of 5.5 to 6.0.
55 . The anti-CD40 antibody formulation of claim 54 , wherein the buffer is a histidine buffer.
56 . The anti-CD40 antibody formulation of claim 55 , wherein the histidine buffer has a concentration of 10 mM to 30 mM.
57 . The anti-CD40 antibody formulation of claim 56 , wherein the histidine buffer has a concentration of 20 mM.
58 . The anti-CD40 antibody formulation of any one of claims 54 - 57 , further comprising arginine.
59 . The anti-CD40 antibody formulation of claim 58 , wherein the arginine is present at a concentration of 140 mM to 160 mM.
60 . The anti-CD40 antibody formulation of claim 59 , wherein the arginine is present at a concentration of 150 mM.
61 . The anti-CD40 antibody formulation of any one of claims 54 - 60 , further comprising sucrose.
62 . The anti-CD40 antibody formulation of claim 61 , wherein the sucrose is present at a concentration of 200 mM to 400 mM.
63 . The anti-CD40 antibody formulation of claim 62 , wherein the sucrose is present at a concentration of 300 mM.
64 . An anti-CD40 antibody formulation, comprising:
at least 150 mg/ml anti-CD40 antibody;
20 mM buffer containing histidine; and
150 mM arginine, wherein the formulation has a pH value of 5.5 to 6.0.
65 . The anti-CD40 antibody formulation of claim 64 , further comprising 300 mM sucrose.
66 . A method of producing an anti-CD40 antibody formulation, the method comprising:
combining 100 mg/ml to 300 mg/ml anti-CD40 antibody in histidine buffer; and
adjusting pH of the formulation to 5.5 to 6.5.
67 . The method of claim 66 , wherein the histidine buffer has a concentration of 10 mM to 30 mM.
68 . The method of claim 67 , wherein the histidine buffer has a concentration of 20 mM.