HYPERIMMUNE GLOBULIN FORMULATIONS
The present disclosure provides hyperimmune globulin pharmaceutical formulations comprising proline, wherein the formulation has a pH greater than 5.4 to about 6.0. Also provided are methods of stabilizing the formulations disclosed herein.
1 . A pharmaceutical formulation comprising:
(a) a mixture of immune globulins or antigen-binding fragments thereof; and
(b) proline;
wherein the formulation has a pH greater than 5.4 to about 6.0.
2 . A pharmaceutical formulation comprising:
(a) a mixture of immune globulins or antigen-binding fragments thereof;
(b) proline; and
(c) a stabilizer
wherein the formulation has a pH greater than 5.4 to about 6.0.
3 . The formulation of claim 1 , wherein the mixture of immune globulins or antigen-binding fragments thereof comprises immunoglobulin G (IgG) or antigen-binding fragments thereof.
4 . The formulation of claim 1 , wherein the mixture of immune globulins or antigen-binding fragments thereof comprises mammalian immune globulins or antigen-binding fragments thereof.
5 .- 6 . (canceled)
7 . The formulation of claim 1 , wherein the formulation has a pH from 5.6 to about 5.8.
8 .- 9 . (canceled)
10 . The formulation of claim 1 , wherein the mixture of immune globulins or antigen-binding fragments thereof is present in the formulation in a concentration ranging from about 60 mg/mL to about 250 mg/mL.
11 .- 15 . (canceled)
16 . The formulation of claim 2 , wherein the stabilizer is selected from the group consisting of polysorbate 20, polysorbate 60, polysorbate 80, poloxamer 184, poloxamer 188, and combinations thereof.
17 .- 18 . (canceled)
19 . The formulation of claim 16 , wherein the stabilizer is present in the formulation in a concentration ranging from about 0.1 mg/mL to about 0.4 mg/mL.
20 . The formulation of claim 1 , wherein the mixture of immune globulins or antigen-binding fragments thereof acts as a buffer, and wherein the formulation does not comprise an additional buffer.
21 . The formulation of claim 1 , wherein the formulation further comprises a buffer.
22 . (canceled)
23 . The formulation of claim 1 , wherein the formulation has a purity of at least about 95%.
24 . The formulation of claim 1 , wherein the formulation does not comprise sugar.
25 . (canceled)
26 . The formulation of claim 1 , wherein the formulation comprises:
(a) a mixture of immune globulins or antigen-binding fragments thereof at a concentration of about 60 mg/mL;
(b) proline at a concentration of about 250 mM; and
(c) polysorbate 80 at concentration of about 0.3 mg/mL;
wherein the formulation has a pH of 5.7.
27 . The formulation of claim 1 , comprising:
(a) a mixture of immune globulins or antigen-binding fragments thereof at a concentration of about 60 mg/mL;
(b) acetate buffer;
(c) proline at a concentration of about 200 mM; and
(d) polysorbate 80 at a concentration of about 0.3 mg/mL;
wherein the formulation has a pH of 5.7.
28 . The formulation of claim 1 , wherein the mixture comprises immune globulins or antigen-binding fragments thereof that specifically bind at least one of an influenza A virus, an influenza B virus, or a coronavirus.
29 . The formulation of claim 28 , wherein the mixture comprises immune globulins or antigen-binding fragments thereof that specifically bind influenza A virus.
30 . The formulation of claim 29 , comprising:
(a) a mixture of immune globulins or antigen-binding fragments thereof;
(b) proline; and
(c) polysorbate 80 (PS80)
wherein the formulation has a pH ranging from 5.5 to about 6.0;
wherein the immune globulins or antigen-binding fragments thereof immunospecifically bind to influenza A.
31 .- 33 . (canceled)
34 . The formulation of claim 28 , wherein the mixture comprises immune globulins or antigen-binding fragments thereof that specifically bind to SARS-CoV-2.
35 . The formulation of claim 34 , comprising:
(a) a mixture of immune globulins or antigen-binding fragments thereof,
(b) proline; and
(c) polysorbate 80 (PS80)
wherein the formulation has a pH ranging from 5.5 to about 6.0;
wherein the immune globulins or antigen-binding fragments thereof immunospecifically bind to SARS-CoV-2.
36 .- 37 . (canceled)
38 . The formulation of claim 1 , wherein the formulation is administered intravenously or intramuscularly.
39 . (canceled)
40 . A method of stabilizing a pharmaceutical formulation comprising a mixture of immune globulins or antigen-binding fragments thereof and proline, the method comprising adjusting the pH of the formulation to at least 5.5, at least 5.6 or at least 5.7.
41 .- 47 . (canceled)