US2021393530A1PendingUtilityA1
VEGF Antagonist Formulations
Est. expiryMar 25, 2025(expired)· nominal 20-yr term from priority
A61P 35/00A61K 47/26C07K 14/71A61K 31/7012A61P 7/00A61K 38/16A61K 9/19A61K 39/39591A61K 9/08A61P 43/00C07K 2318/20A61K 38/17A61K 38/179A61K 9/0019A61K 47/183A61K 47/12A61P 9/00A61K 31/4172A61K 47/02C07K 16/22C07K 2319/30A61K 47/22A61K 47/10Y02A50/30
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Claims
Abstract
Formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided including a pre-lyophilized formulation, a reconstituted lyophilized formulation, and a stable liquid formulation. Preferably, the fusion protein has the sequence of SEQ ID NO:4.
Claims
exact text as granted — not AI-modified1 .- 20 . (canceled)
21 . A pre-filled syringe comprising a formulation comprising:
10-50 mg/ml of a vascular endothelial growth factor (VEGF) antagonist fusion protein comprising amino acids 27-457 of SEQ ID NO: 4, a pH of 6.0-6.5, an organic co-solvent, a stabilizing agent comprising a sugar, an amino acid, or both, and wherein said VEGF antagonist fusion protein exhibits less than 3% degradation after 15 months of storage at 5° C.
22 . The pre-filled syringe of claim 21 , wherein said sugar comprises a sugar selected from group consisting of dextrose, ribose, fructose, mannitol, inositol, sorbitol, trehalose, sucrose, and lactose.
23 . The pre-filled syringe of claim 21 , wherein said sugar comprises sucrose, trehalose, or mannitol.
24 . The pre-filled syringe of claim 23 , wherein said sugar comprises trehalose.
25 . The pre-filled syringe of claim 23 , wherein said sugar comprises sucrose.
26 . The pre-filled syringe of claim 23 , wherein said sugar comprises 5-30% sucrose.
27 . The pre-filled syringe of claim 23 , wherein said sugar comprises 5-20% sucrose.
28 . The pre-filled syringe of claim 25 , wherein said sugar further comprises trehalose.
29 . The pre-filled syringe of claim 23 , wherein said co solvent comprises polysorbate.
30 . The pre-filled syringe of claim 29 , wherein said co solvent comprises polysorbate 20.
31 . The pre-filled syringe of claim 29 , wherein said pH is 6.2.
32 . The pre-filled syringe of claim 31 , wherein said formulation further comprises a tonicity agent.
33 . The pre-filled syringe of claim 32 , wherein said tonicity agent is sodium chloride.
34 . The pre-filled syringe of claim 21 , wherein said stabilizing agent comprises an amino acid.
35 . The pre-filled syringe of claim 34 , wherein said pH is 6.2.
36 . The pre-filled syringe of claim 34 , wherein said co solvent comprises polysorbate.
37 . The pre-filled syringe of claim 36 , wherein said co solvent comprises polysorbate 20.
38 . The pre-filled syringe of claim 35 , wherein said formulation further comprises a tonicity agent.
39 . The pre-filled syringe of claim 38 , wherein said tonicity agent is sodium chloride.
40 . The pre-filled syringe of claim 21 , wherein said formulation comprises 40 mg/ml of said VEGF antagonist fusion protein.
41 . The pre-filled syringe of claim 40 , wherein said sugar comprises a sugar selected from group consisting of dextrose, ribose, fructose, mannitol, inositol, sorbitol, trehalose, sucrose, and lactose.
42 . The pre-filled syringe of claim 40 , wherein said sugar comprises sucrose, trehalose, or mannitol.
43 . The pre-filled syringe of claim 42 , wherein said sugar comprises trehalose.
44 . The pre-filled syringe of claim 42 , wherein said sugar comprises sucrose.
45 . The pre-filled syringe of claim 42 , wherein said sugar comprises 5-30% sucrose.
46 . The pre-filled syringe of claim 42 , wherein said sugar comprises 5-20% sucrose.
47 . The pre-filled syringe of claim 42 , wherein said co solvent comprises polysorbate.
48 . The pre-filled syringe of claim 47 , wherein said co solvent comprises polysorbate 20.
49 . The pre-filled syringe of claim 47 , wherein said pH is 6.2.
50 . The pre-filled syringe of claim 49 , wherein said formulation further comprises a tonicity agent.
51 . The pre-filled syringe of claim 50 , wherein said tonicity agent is sodium chloride.
52 . The pre-filled syringe of claim 40 , wherein said stabilizing agent comprises an amino acid.
53 . The pre-filled syringe of claim 52 , wherein said pH is 6.2.
54 . The pre-filled syringe of claim 52 , wherein said co solvent comprises polysorbate.
55 . The pre-filled syringe of claim 54 , wherein said co solvent comprises polysorbate 20.
56 . The pre-filled syringe of claim 53 , wherein said formulation further comprises a tonicity agent.
57 . The pre-filled syringe of claim 56 , wherein said tonicity agent is sodium chloride.
58 . A vial comprising a formulation comprising:
10-50 mg/ml of a vascular endothelial growth factor (VEGF) antagonist fusion protein comprising amino acids 27-457 of SEQ ID NO: 4, a pH of 6.0-6.5, an organic co-solvent, a stabilizing agent comprising a sugar, an amino acid, or both, and wherein said VEGF antagonist fusion protein exhibits less than 3% degradation after 15 months of storage at 5° C.
59 . The vial of claim 58 , wherein said sugar comprises a sugar selected from group consisting of dextrose, ribose, fructose, mannitol, inositol, sorbitol, trehalose, sucrose, and lactose.
60 . The vial of claim 58 , wherein said sugar comprises sucrose, trehalose, or mannitol.
61 . The vial of claim 60 , wherein said sugar comprises trehalose.
62 . The vial of claim 60 , wherein said sugar comprises sucrose.
63 . The vial of claim 60 , wherein said sugar comprises 5-30% sucrose.
64 . The vial of claim 60 , wherein said sugar comprises 5-20% sucrose.
65 . The vial of claim 60 , wherein said cosolvent comprises polysorbate.
66 . The vial of claim 65 , wherein said cosolvent comprises polysorbate 20.
67 . The vial of claim 65 , wherein said pH is 6.2.
68 . The vial of claim 67 , wherein said formulation further comprises a tonicity agent.
69 . The vial of claim 68 , wherein said tonicity agent is sodium chloride.
70 . The vial of claim 58 , wherein said stabilizing agent comprises an amino acid.
71 . The vial of claim 70 , wherein said pH is 6.2.
72 . The vial of claim 70 , wherein said cosolvent comprises polysorbate.
73 . The vial of claim 72 , wherein said cosolvent comprises polysorbate 20.
74 . The vial of claim 71 , wherein said formulation further comprises a tonicity agent.
75 . The vial of claim 74 wherein said tonicity agent is sodium chloride.
76 . The vial of claim 69 , wherein said formulation comprises 40 mg/ml of said VEGF antagonist fusion protein.
77 . The vial of claim 76 , wherein said sugar comprises a sugar selected from group consisting of dextrose, ribose, fructose, mannitol, inositol, sorbitol, trehalose, sucrose, and lactose.
78 . The vial of claim 76 , wherein said sugar comprises sucrose, trehalose, or mannitol.
79 . The vial of claim 78 , wherein said sugar comprises trehalose.
80 . The vial of claim 78 , wherein said sugar comprises sucrose.
81 . The vial of claim 78 , wherein said sugar comprises 5-30% sucrose.
82 . The vial of claim 78 , wherein said sugar comprises 5-20% sucrose.
83 . The vial of claim 78 , wherein said cosolvent comprises polysorbate.
84 . The vial of claim 83 , wherein said cosolvent comprises polysorbate 20.
85 . The vial of claim 83 , wherein said pH is 6.2.
86 . The vial of claim 85 , wherein said formulation further comprises a tonicity agent.
87 . The vial of claim 86 , wherein said tonicity agent is sodium chloride.
88 . The vial of claim 76 , wherein said stabilizing agent comprises an amino acid.
89 . The vial of claim 88 , wherein said pH is 6.2.
90 . The vial of claim 88 , wherein said cosolvent comprises polysorbate.
91 . The vial of claim 90 , wherein said cosolvent comprises polysorbate 20.
92 . The vial of claim 89 , wherein said formulation further comprises a tonicity agent.
93 . The vial of claim 90 , wherein said tonicity agent is sodium chloride.Join the waitlist — get patent alerts
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