SOLUTION FORMULATIONS OF ENGINEERED ANTI-IL-23p19 ANTIBODIES
The present invention provides high concentration solution formulations of anti-human interleukin-23 p19 (IL-23p19) antibody hum1388-b, and their use in treating various disorders.
1 : A pharmaceutical formulation comprising an anti-IL-23p19 antibody hum13B8-b, wherein the anti-IL-23p19 antibody hum13B8-b comprises a light chain polypeptide having the amino acid sequence of SEQ ID NO: 2 and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 1, and wherein the formulation comprises no more than about 25.4% acidic variants of the anti-IL-23p19 antibody hum13B8-b.
2 : The pharmaceutical formulation of claim 1 , wherein the formulation, after storage at about 25° C. for at least 12 months, comprises:
(a) no more than 25.4% acidic variants of the anti-IL-23p19 antibody hum13B8-b;
(b) no more than 4.2% basic variants of the anti-IL-23p19 antibody hum13B8-b;
(c) no more than 2.69% high molecular weight (HMW) species of the anti-IL-23p19 antibody hum13B8-b;
(d) no more than 0.86% low molecular weight (LMW) species of the anti-IL-23p19 antibody hum13B8-b; and
(e) at least 96.2% anti-IL-23p19 antibody hum13B8-b monomers.
3 : The pharmaceutical formulation of claim 2 , wherein the percentage of acid variants and/or basic variants is measured by high performance ion exchange chromatography (HP-IEX).
4 : The pharmaceutical formulation of claim 2 , wherein the percentage of HMW species, LMW species, and/or monomers is measured by high performance size exclusion chromatography (HP-SEC).
5 : The pharmaceutical formulation of claim 1 , wherein the formulation, after storage at 5°±3° C. for at least 12 months, comprises:
(a) no more than 18.2% acidic variants of the anti-IL-23p19 antibody hum13B8-b;
(b) no more than 16.8% basic variants of the anti-IL-23p19 antibody hum13B8-b;
(c) no more than 0.84% high molecular weight (HMW) species of the anti-IL-23p19 antibody hum13B8-b; and
(d) at least 98.9% anti-IL-23p19 antibody hum13B8-b monomers.
6 : The pharmaceutical formulation of claim 5 , wherein the percentage of acid variants and/or basic variants is measured by high performance ion exchange chromatography (HP-IEX).
7 : The pharmaceutical formulation of claim 5 , wherein the percentage of HMW species and/or monomers is measured by high performance size exclusion chromatography (HP-SEC).
8 : The pharmaceutical formulation of claim 1 , wherein the formulation comprises at least 90 to 110 mg/mL anti-IL-23p19 antibody hum13B8-b.
9 : The pharmaceutical formulation of claim 8 , wherein the formulation comprises at least 100 mg/mL anti-IL-23p19 antibody hum13B8-b.
10 : The pharmaceutical formulation of claim 1 , wherein the formulation comprises a buffer, a surfactant, and tonicity adjustment agent.
11 : The pharmaceutical formulation of claim 10 , wherein the buffer is histidine or acetate.
12 : The pharmaceutical formulation of claim 10 , wherein the surfactant is polysorbate 80, polysorbate 20, or poloxamer 188.
13 : The pharmaceutical formulation of claim 10 , wherein the tonicity adjustment agent is sucrose, trehlose, or mannitol.
14 : The pharmaceutical formulation of claim 10 , wherein the buffer is 10 mM histidine, the surfactant is 0-0.05% (w/v) of polysorbate 80, and the tonicity adjustment agent is 7% (w/v) sucrose.
15 : The pharmaceutical formulation of claim 1 , wherein the formulation is in a pre-filled syringe or autoinjector.
16 : The pharmaceutical formulation of claim 1 , wherein the formulation is for subcutaneous administration.
17 : A pharmaceutical formulation comprising an anti-IL-23p19 antibody hum13B8-b, wherein the anti-IL-23p19 antibody hum13B8-b comprises a light chain polypeptide having the amino acid sequence of SEQ ID NO: 2 and a heavy chain polypeptide having the amino acid sequence of SEQ ID NO: 1, and wherein the formulation comprises no more than about 19.1% acidic variants of the anti-IL-23p19 antibody hum13B8-b.
18 : The pharmaceutical formulation of claim 17 , wherein the formulation, after storage at 5°±3° C. for at least 24 months, comprises:
(a) no more than 19.1% acidic variants of the anti-IL-23p19 antibody hum13B8-b;
(b) no more than 15.8% basic variants of the anti-IL-23p19 antibody hum13B8-b;
(c) no more than 1.24% high molecular weight (HMW) species of the anti-IL-23p19 antibody hum13B8-b; and
(d) at least 98.5% anti-IL-23p19 antibody hum13B8-b monomers.
19 : The pharmaceutical formulation of claim 18 , wherein the percentage of acid variants and/or basic variants is measured by high performance ion exchange chromatography (HP-IEX).
20 : The pharmaceutical formulation of claim 18 , wherein the percentage of HMW species and/or monomers is measured by high performance size exclusion chromatography (HP-SEC).
21 : The pharmaceutical formulation of claim 17 , wherein the formulation comprises at least 90 to 110 mg/mL anti-IL-23p19 antibody hum13B8-b.
22 : The pharmaceutical formulation of claim 21 , wherein the formulation comprises at least 100 mg/mL anti-IL-23p19 antibody hum13B8-b.
23 : The pharmaceutical formulation of claim 17 , wherein the formulation comprises a buffer, a surfactant, and tonicity adjustment agent.
24 : The pharmaceutical formulation of claim 23 , wherein the buffer is histidine or acetate.
25 : The pharmaceutical formulation of claim 23 , wherein the surfactant is polysorbate 80, polysorbate 20, or poloxamer 188.
26 : The pharmaceutical formulation of claim 23 , wherein the tonicity adjustment agent is sucrose, trehlose, or mannitol.
27 : The pharmaceutical formulation of claim 23 , wherein the buffer is 10 mM histidine, the surfactant is 0-0.05% (w/v) of polysorbate 80, and the tonicity adjustment agent is 7% (w/v) sucrose.
28 : The pharmaceutical formulation of claim 17 , wherein the formulation is in a pre-filled syringe or autoinjector.
29 : The pharmaceutical formulation of claim 17 , wherein the formulation is for subcutaneous administration.